FUJIREBIO

FUJIREBIO

Fujirebio is a global leader in the field of IVD testing with more than 50 years’ experience in the conception, development, production and worldwide commercialization of robust IVD products. These span the range from specialized testing to fully automated routine clinical laboratory testing solutions covering a variet ...
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Covid-19 FUJIREBIO

Laboratorio clínico

Flu A/B & SARS-CoV-2 Real-Time RT-PCR Test
DiaPlexQ Flu A/B & SARS-CoV-2

DiaPlexQ Flu A/B & SARS-CoV-2 is a Real-time RT-PCR test for the qualitative detection of HA gene from Influenza A/B virus and N and ORF1a gene from SARS-CoV-2 in nasopharyngeal swab.
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PRUEBA DE RT-PCR SARS-COV-2 (ORF1A, N, RDRP)
DiaPlexQ SARS-CoV-2 (ORF1a, N, RdRp)

DiaPlexQ SARS-CoV-2 (ORF1a, N, RdRp) es una prueba de RT-PCR en tiempo real para la detección cualitativa de ácidos nucleicos de SARS-CoV-2 en varios tipos de muestras.
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PRUEBA AUTOMATIZADA DE PROCALCITONINA (PCT)
Lumipulse G B•R•A•H•M•S PCT

Los cartuchos de inmunorreacción Lumipulse G BRAHMS PCT son para uso de diagnóstico in vitro (IVD) con el método de inmunoensayo sándwich de dos pasos en el sistema LUMIPULSE G para la determinación cuantitativa de procalcitonina (PCT).
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ENSAYO RT-ISOTÉRMICO FLUORESCENTE COVID-19
iAMP COVID-19 SANO Assay

El iAMP COVID-19 SANO es un ensayo RT-isotérmico fluorescente en tiempo real basado en la tecnología de amplificación isotérmica patentada de Atila, destinada a la detección cualitativa de ácido nucleico del SARS-CoV-2.
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SARS-CoV-2 S-IgG Antibody Assay
Lumipulse G SARS-CoV-2 S-IgG

Lumipulse G SARS-CoV-2 S-IgG is an assay system, including a set of immunoassay reagents, for the quantitative measurement of IgG-type antibodies SARS-CoV-2 spike protein (SARS-CoV-2 S-IgG) in specimens based on CLEIA technology. The CE marked assay system has a specific two-step immunoassay method and runs on the LUMIPULSE G System with results available in up to 30 minutes.
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PRUEBA DE ANTICUERPOS SARS-COV-2
Lumipulse G SARS-CoV-2 Ag

La prueba Lumipulse G SARS-CoV-2 Ag fue diseñada para uso diagnóstico in vitro (IVD) con el sistema Lumipulse G para la detección y medición cuantitativa del antígeno SARS-CoV-2 en hisopados nasofaríngeos o saliva humana.
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SARS-CoV-2 Ag Controls
Lumipulse® SARS-CoV-2 Ag Controls

The CE marked Lumipulse® SARS-CoV-2 Ag Controls are intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analysis of SARS-CoV-2 antigen on the LUMIPULSE G System.
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BNP Control
Lumipulse® BNP Control

The CE marked Lumipulse® BNP Control are intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of human B-type natriuretic peptide (BNP) on the LUMIPULSE G Systems.
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AMH Immunoreaction Cartridges
Lumipulse® G AMH (anti-Müllerian hormone)

The CE marked Lumipulse® G AMH (anti-Müllerian hormone) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the fully automated quantitative measurement of AMH in specimens based a two-step immunoassay method on the LUMIPULSE G System. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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LH Immunoreaction Cartridges
Lumipulse® G LH (Luteinizing Hormone)

The CE marked Lumipulse® G LH (Luteinizing Hormone) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of luteinizing hormone (LH) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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HIV p24 Antigen Test
INNOTEST® HIV Antigen mAb

The CE marked INNOTEST® HIV Antigen mAb is an enzyme immunoassay for the qualitative detection of HIV p24 antigen in human serum, plasma, and cell culture supernatant. The kit contains reagents for confirmation of HIV p24 antigens in repeatedly reactive samples.
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COVID-19 Test
iAMP COVID-19 Detection Kit

The CE marked iAMP COVID-19 Detection Kit is designed for the qualitative nucleic acid detection of SARS-CoV-2 (COVID-19) on naso- or oropharyngeal swabs without pre-treatment. Using isothermal amplification with real time fluorescence detection, the kit requires limited hands-on time and delivers fast sample-to-result within 75 to 90 minutes only.
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SARS-CoV-2 Assay
ESPLINE® SARS-CoV-2

The CE marked ESPLINE® SARS-CoV-2 is a cassette-style immunochromatographic assay for in vitro diagnostic (IVD) use for the detection of SARS-CoV-2 antigen directly from nasopharyngeal swab fluid. It can detect SARS-CoV-2 within 30 minutes using a simple procedure without any special instruments and is intended for use as an aid in the diagnosis of SARS-CoV-2 infection.
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Actualizado

PRUEBA DE RT-PCR SARS-COV-2 (ORF1A, N, RDRP)
DiaPlexQ SARS-CoV-2 (ORF1a, N, RdRp)

DiaPlexQ SARS-CoV-2 (ORF1a, N, RdRp) es una prueba de RT-PCR en tiempo real para la detección cualitativa de ácidos nucleicos de SARS-CoV-2 en varios tipos de muestras.
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Flu A/B & SARS-CoV-2 Real-Time RT-PCR Test
DiaPlexQ Flu A/B & SARS-CoV-2

DiaPlexQ Flu A/B & SARS-CoV-2 is a Real-time RT-PCR test for the qualitative detection of HA gene from Influenza A/B virus and N and ORF1a gene from SARS-CoV-2 in nasopharyngeal swab.
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SARS-CoV-2 S-IgG Antibody Assay
Lumipulse G SARS-CoV-2 S-IgG

Lumipulse G SARS-CoV-2 S-IgG is an assay system, including a set of immunoassay reagents, for the quantitative measurement of IgG-type antibodies SARS-CoV-2 spike protein (SARS-CoV-2 S-IgG) in specimens based on CLEIA technology. The CE marked assay system has a specific two-step immunoassay method and runs on the LUMIPULSE G System with results available in up to 30 minutes.
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Laboratorio clínico

PRUEBA DE RT-PCR SARS-COV-2 (ORF1A, N, RDRP)
DiaPlexQ SARS-CoV-2 (ORF1a, N, RdRp)

DiaPlexQ SARS-CoV-2 (ORF1a, N, RdRp) es una prueba de RT-PCR en tiempo real para la detección cualitativa de ácidos nucleicos de SARS-CoV-2 en varios tipos de muestras.
Mas detalles

Flu A/B & SARS-CoV-2 Real-Time RT-PCR Test
DiaPlexQ Flu A/B & SARS-CoV-2

DiaPlexQ Flu A/B & SARS-CoV-2 is a Real-time RT-PCR test for the qualitative detection of HA gene from Influenza A/B virus and N and ORF1a gene from SARS-CoV-2 in nasopharyngeal swab.
Mas detalles

SARS-CoV-2 S-IgG Antibody Assay
Lumipulse G SARS-CoV-2 S-IgG

Lumipulse G SARS-CoV-2 S-IgG is an assay system, including a set of immunoassay reagents, for the quantitative measurement of IgG-type antibodies SARS-CoV-2 spike protein (SARS-CoV-2 S-IgG) in specimens based on CLEIA technology. The CE marked assay system has a specific two-step immunoassay method and runs on the LUMIPULSE G System with results available in up to 30 minutes.
Mas detalles

ENSAYO RT-ISOTÉRMICO FLUORESCENTE COVID-19
iAMP COVID-19 SANO Assay

El iAMP COVID-19 SANO es un ensayo RT-isotérmico fluorescente en tiempo real basado en la tecnología de amplificación isotérmica patentada de Atila, destinada a la detección cualitativa de ácido nucleico del SARS-CoV-2.
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PRUEBA AUTOMATIZADA DE PROCALCITONINA (PCT)
Lumipulse G B•R•A•H•M•S PCT

Los cartuchos de inmunorreacción Lumipulse G BRAHMS PCT son para uso de diagnóstico in vitro (IVD) con el método de inmunoensayo sándwich de dos pasos en el sistema LUMIPULSE G para la determinación cuantitativa de procalcitonina (PCT).
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Tumor Marker Control
Tumor Marker Control

The CE marked Tumor Marker Control can be used by laboratories as an independent internal quality control to monitor the performance of their tumor marker testing.
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Mesothelin Control
Mesothelin Control

The CE marked Mesothelin assayed quality control serum is intended to monitor precision of laboratory testing procedures for the analysis of the soluble mesothelin related peptides (SMRP) with the LUMIPULSE G system.
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Lung Marker Control
Lung Marker Control

The CE marked Lung Marker Control is an assayed, two-level control containing Cyfra and ProGRP antigens.
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β-Amyloid Control
Lumipulse® β-Amyloid Control

The CE marked Lumipulse® β-Amyloid Controls are intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of β-Amyloid 1-40 and 1-42 using LUMIPULSE G Systems.
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Total Tau Control
Lumipulse® Total Tau Control

The CE marked Lumipulse® Total Tau Controls are intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of total Tau using LUMIPULSE G Systems.
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SARS-CoV-2 Ag Controls
Lumipulse® SARS-CoV-2 Ag Controls

The CE marked Lumipulse® SARS-CoV-2 Ag Controls are intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analysis of SARS-CoV-2 antigen on the LUMIPULSE G System.
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PTH Control
Lumipulse® PTH Control

The CE marked Lumipulse® PTH Controls are intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of whole (1-84) PTH on the LUMIPULSE G Systems.
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pTau 181 Control
Lumipulse® pTau 181 Control

The CE marked Lumipulse® pTau 181 Controls are intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of pTau using LUMIPULSE G Systems.
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PIVKA-II and KL-6 Control
Lumipulse® PIVKA-II and KL-6 Contro

The CE marked Lumipulse® PIVKA-II and KL-6 Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of PIVKA-II and KL-6 using LUMIPULSE Systems.
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Pepsinogen I/II Control
Lumipulse® Pepsinogen I/II Control

The CE marked Lumipulse® Pepsinogen I/II controls are intended for use as an assayed control to monitor the precision of laboratory testing procedures for the analysis of Pepsinogen I and Pepsinogen II on the LUMIPULSE G Systems.
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HBcrAg Controls
Lumipulse® HBcrAg Controls (RUO)

The Lumipulse® HBcrAg Controls (RUO) are intended for use as an assayed control material to monitor the precision of laboratory testing procedures for the analysis of HBcrAg using LUMIPULSE G Systems.
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βHCG Immunoreaction Cartridges
Lumipulse® G βHCG (Beta Human Chorionic Gonadotropin)

The CE marked Lumipulse® G βHCG (Beta Human Chorionic Gonadotropin) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of beta human chorionic gonadotropin (βHCG) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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β2M-N Immunoreaction Cartridges
Lumipulse® G β2M-N (Beta 2-microglobulin)

The CE marked Lumipulse® G β2M-N (Beta 2-microglobulin) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of Beta 2-microglobulin (β2-m) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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ß2M-N Immunoreaction Cartridges
Lumipulse® G β2M-N (Beta 2-microglobulin)

The CE marked Lumipulse® G β2M-N (Beta 2-microglobulin) immunoreaction cartridges are intended for in vitro diagnostics (IVD) use with the LUMIPULSE G System for the quantitative measurement of ß2-microglobulin (ß2m) in serum, plasma and urine.
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β-Amyloid 1-42 Immunoreaction Cartridges
Lumipulse® G β-Amyloid 1-42

The CE marked Lumipulse® G β-Amyloid 1-42 immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of β-amyloid in human cerebrospinal fluid. This CSF biomarker is intended to be used as an aid for diagnosis in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline.
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β-Amyloid 1-40 Immunoreaction Cartridges
Lumipulse® G β-Amyloid 1-40

The CE marked Lumipulse® G β-Amyloid 1-40 immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of β-amyloid1-40 in human cerebrospinal fluid (CSF). The Lumipulse G β-Amyloid 1-40 assay is intended to be used in conjunction with Lumipulse G β-Amyloid 1-42 assay to determine the amyloid ratio (β-amyloid1-42 / β-amyloid1-40 ratio) in the clinical setting of dementia diagnosis. This CSF amyloid ratio (β-amyloid1-42 / β-amyloid1-40 ratio) is intended to be used as an aid for diagnosis in patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. The CSF amyloid ratio supports the probability of AD pathology only as an adjunct to other diagnostic evaluations.
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Whole PTH Immunoreaction Cartridges
Lumipulse® G whole PTH

The CE marked Lumipulse® G whole PTH immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of whole (1-84) PTH in human serum or plasma based on CLEIA technology by a one-step sandwich immunoassay method on the LUMIPULSE G System with results that are available in up to 35 minutes.
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TSH-III Immunoreaction Cartridges
Lumipulse® G TSH-III (Thyroid-Stimulating Hormone)

The CE marked Lumipulse® G TSH-III (Thyroid-Stimulating Hormone) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of thyroid-stimulating hormone (TSH) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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TPOAb Immunoreaction Cartridges
Lumipulse® G TPOAb (Anti-Thyroid Peroxidase Antibodies)

The CE marked Lumipulse® G TPOAb (Anti-Thyroid Peroxidase Antibodies) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of Anti-Thyroid Peroxidase Antibodies (TPOAb) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes. The kit includes calibrators.
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TP-N Immunoreaction Cartridges
Lumipulse® G TP-N (Treponema Pallidum)

The CE marked Lumipulse® G TP-N (Treponema Pallidum) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the qualitative measurement of treponema pallidum (TP) antibodies (IgG and IgM) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes. The kit includes calibrators.
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Total Tau Immunoreaction Cartridges
Lumipulse® G Total Tau

The CE marked Lumipulse® G Total Tau immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of total Tau in human cerebrospinal fluid (CSF). This CSF biomarker is intended to be used as an aid for diagnosis in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline.
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TgAb Immunoreaction Cartridges
Lumipulse® G TgAb (Anti-Thyroglobulin Antibodies)

The CE marked Lumipulse® G TgAb (Anti-Thyroglobulin Antibodies) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes. The kit includes calibrators.
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Testosterone Immunoreaction Cartridges
Lumipulse® G Testosterone

The CE marked Lumipulse® G Testosterone immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of testosterone in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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T4 Immunoreaction Cartridges
Lumipulse® G T4 (Thyroxine)

The CE marked Lumipulse® G T4 (Thyroxine) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of thyroxine (T4) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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T3 Immunoreaction Cartridges
Lumipulse® G T3 (Triiodothyronine)

The CE marked Lumipulse® G T3 (Triiodothyronine) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of triiodothyronine (T3) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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SCC Immunoreaction Cartridges
Lumipulse® G SCC (Squamous Cell Carcinoma)

The CE marked Lumipulse® G SCC (Squamous Cell Carcinoma) immunoreaction cartridges are intended for in vitro diagnostic use with the LUMIPULSE G instruments for the quantitative measurement of squamous cell carcinoma (SCC) antigen in human serum or plasma samples as an aid in the management of patients with squamous cell carcinoma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme ImmunoAssay) technology with results that are available in up to 35 minutes.
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Renin Immunoreaction Cartridges
Lumipulse® G Renin

The CE marked Lumipulse® G Renin immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of active renin in human serum or plasma.
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pTau 181 Immunoreaction Cartridges
Lumipulse® G pTau 181

The CE marked Lumipulse® G pTau 181 immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of Tau phosphorylated at threonine 181 (pTau 181) in human cerebrospinal fluid (CSF). This CSF biomarker is intended to be used as an aid for diagnosis in patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. The CSF biomarker supports the probability of AD pathology only as an adjunct to other diagnostic evaluations.
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PSA-N Immunoreaction Cartridges
Lumipulse® G PSA-N (Prostate Specific Antigen)

The CE marked Lumipulse® G PSA-N (Prostate Specific Antigen) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of prostate specific antigen (PSA) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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Prolactin Immunoreaction Cartridges
Lumipulse® G Prolactin

The CE marked Lumipulse® G Prolactin immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of prolactin in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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ProGRP Immunoreaction Cartridges
Lumipulse® G ProGRP (Pro-Gastrin-Releasing Peptide)

The CE marked Lumipulse® G ProGRP (Pro-Gastrin-Releasing Peptide) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of Pro-gastrin-releasing peptide [ProGRP (31-98)] in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes. The ProGRP assay is intended to be used as an aid in differential diagnosis and for monitoring of patients with Small Cell Lung Cancer.
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Progesterone-N Immunoreaction Cartridges
Lumipulse® G Progesterone-N

The CE marked Lumipulse® G Progesterone-N immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of Progesterone in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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PIVKA-II Immunoreaction Cartridges
Lumipulse® G PIVKA-II

The CE marked Lumipulse® G PIVKA-II immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of protein induced vitamin K absence or antagonist-II (PIVKA-II) in serum. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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Pepsinogen II Immunoreaction Cartridges
Lumipulse® G Pepsinogen II

The CE marked Lumipulse® G Pepsinogen II unique immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative determination of Pepsinogen II in human serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme ImmunoAssay) technology with results that are available in up to 35 minutes.
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Pepsinogen I Immunoreaction Cartridges
Lumipulse® G Pepsinogen I

The CE marked Lumipulse® G Pepsinogen I unique immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative determination of Pepsinogen I in human serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme ImmunoAssay) technology with results that are available in up to 35 minutes.
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Myoglobin Immunoreaction Cartridges
Lumipulse® G Myoglobin

The CE marked Lumipulse® G Myoglobin immunoreaction cartridges are intended for in vitro diagnostic use with the LUMIPULSE G instruments for the quantitative measurement of myoglobin in human serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme ImmunoAssay) technology with results that are available in up to 35 minutes.
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Mesothelin Immunoreaction Cartridges
Lumipulse® G Mesothelin

The CE marked Lumipulse® G Mesothelin immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative determination Soluble Mesothelin Related Peptides (SMRP) in human serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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LH Immunoreaction Cartridges
Lumipulse® G LH (Luteinizing Hormone)

The CE marked Lumipulse® G LH (Luteinizing Hormone) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of luteinizing hormone (LH) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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KL-6 Immunoreaction Cartridges
Lumipulse® G KL-6 (Krebs von den Lungen)

The CE marked Lumipulse® G KL-6 (Krebs von den Lungen) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of sialylated carbohydrate antigen, KL-6 in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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Insulin-N Immunoreaction Cartridges
Lumipulse® G Insulin-N

The CE marked Lumipulse® G Insulin-N immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of insulin in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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IgE (Immunoglobulin E) Immunoreaction Cartridges
Lumipulse® G IgE (Immunoglobulin E)

The CE marked Lumipulse® G IgE (Immunoglobulin E) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of immunoglobulin E (IgE) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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hs Troponin I Immunoreaction Cartridges
Lumipulse® G hs Troponin I

The CE marked Lumipulse® G hs Troponin I immunoreaction cartridges are intended for in vitro diagnostic use with the LUMIPULSE G instruments for the quantitative and high sensitive measurement of cardiac Troponin-I (cTnI) in human serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme ImmunoAssay) technology with results that are available in up to 35 minutes.
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HMW Adiponectin Immunoreaction Cartridges
Lumipulse® G HMW Adiponectin

The CE marked Lumipulse® G HMW Adiponectin unique mono-test immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of high-molecular-weight adiponectin (HMW Adiponectin) in serum or plasma. The assay utilizes proven CLEIA (Chemiluminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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HBsAg-Quant Immunoreaction Cartridges
Lumipulse® G HBsAg-Quant

The CE marked Lumipulse® G HBsAg-Quant immunoreaction cartridges are intended for in vitro diagnostics (IVD) use with the LUMIPULSE G System for the qualitative and quantitative detection of hepatitis B surface antigen (HBsAg) in human serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes. The product is indicated as an aid for screening and diagnosis of hepatitis B viral infection and for professional use only.
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HBeAg Immunoreaction Cartridges
Lumipulse® G HBeAg

The CE marked Lumipulse® G HBeAg immunoreaction cartridges are intended for in vitro diagnostics (IVD) use with the LUMIPULSE G System for the qualitative detection of hepatitis B e antigen (HBeAg) in human serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes. The product is indicated as an aid in the diagnosis and monitoring of hepatitis B viral infection and for professional use only.
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HBeAb-N Immunoreaction Cartridges
Lumipulse® G HBeAb-N

The CE marked Lumipulse® G HBeAb-N immunoreaction cartridges are intended for in vitro diagnostic use with the LUMIPULSE G System for the qualitative detection of antibody to hepatitis B e antigen (anti-HBe) in human serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes. The product is indicated as an aid in the diagnosis and monitoring of hepatitis B viral infection and for professional use only.
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HBcrAg Immunoreaction Cartridges (RUO)
Lumipulse® G HBcrAg (RUO)

The Lumipulse® G HBcrAg immunoreaction cartridges are intended for Research Use Only (not for use in diagnostic procedures) with the LUMIPULSE G System for the quantitative detection of hepatitis B virus core-related antigen in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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HBcIgM Immunoreaction Cartridges
Lumipulse® G HBcIgM

The CE marked Lumipulse® G HBcIgM immunoreaction cartridges are intended for in vitro diagnostics (IVD) use with the LUMIPULSE G System for the qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma. The assay utilises proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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FT4-N Immunoreaction Cartridges
Lumipulse® G FT4-N (Free Thyroxine)

The CE marked Lumipulse® G FT4-N (Free Thyroxine) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of free thyroxine (FT4) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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FT3-III Immunoreaction Cartridges
Lumipulse® G FT3-III (Free Triiodothyronine)

The CE marked Lumipulse® G FT3-III (Free Triiodothyronine) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of free triiodothyronine (FT3) in serum or plasma. This assay uses a mouse monoclonal antibody. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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FSH-N Immunoreaction Cartridges
Lumipulse® G FSH-N (Follicle-Stimulating Hormone)

The CE marked Lumipulse® G FSH-N (Follicle-Stimulating Hormone) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of follicle-stimulating hormone (FSH) in serum or plasma. The assay utilises proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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Free PSA Immunoreaction Cartridges
Lumipulse® G Free PSA (Free Prostate Specific Antigen)

The CE marked Lumipulse® G Free PSA (Free Prostate Specific Antigen) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of free prostate specific antigen (free PSA) in human serum or plasma. The Lumipulse G Free PSA assay is intended to be used in conjunction with the Lumipulse G PSA-N assay to determine the % free PSA value in men aged 50 years or older whose total PSA values are between 4 and 10 ng/mL and whose DRE is not suspicious for cancer. The % free PSA value can be used as an aid in distinguishing prostate cancer from benign disease. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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Ferritin-N Immunoreaction Cartridges
Lumipulse® G Ferritin-N

The CE marked Lumipulse® G Ferritin-N immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of ferritin in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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E2-III Immunoreaction Cartridges
Lumipulse® G E2-III

The CE marked Lumipulse® G E2-III immunoreaction cartridges are intended for in vitro diagnostic use with the LUMIPULSE G System for the quantitative measurement of estradiol (E2) in serum and plasma. E2 measurement can be used for evaluating ovarian function, monitoring of fertility therapy and determining the time of ovulation during in vitro fertilization. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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CYFRA Immunoreaction Cartridges
Lumipulse® G CYFRA (Cytokeratin Subunit 19 Fragment)

The CE marked Lumipulse® G CYFRA (Cytokeratin Subunit 19 Fragment) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of cytokeratin subunit 19 fragment (CYFRA) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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CK-MB Immunoreaction Cartridges
Lumipulse® G CK-MB

The CE marked Lumipulse® G CK-MB immunoreaction cartridges are intended for in vitro diagnostic use with the LUMIPULSE G instruments for the quantitative measurement of the MB iso-enzyme of the creatine kinase (CK-MB) in human serum or plasma. This product is for professional use only. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme ImmunoAssay) technology with results that are available in up to 35 minutes.
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CEA-N Immunoreaction Cartridges
Lumipulse® G CEA-N (Carcinoembryonic Antigen)

The CE marked Lumipulse® G CEA-N (Carcinoembryonic Antigen) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of carcinoembryonic antigen (CEA) in serum or plasma. The assay utilises proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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CA19-9-N Immunoreaction Cartridges
Lumipulse® G CA19-9-N

The CE marked Lumipulse® G CA19-9-N immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of CA19-9-N in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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CA15-3 Immunoreaction Cartridges
Lumipulse® G CA15-3

The CE marked Lumipulse® G CA15-3 immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of CA15-3 in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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CA125-II Immunoreaction Cartridges
Lumipulse® G CA125-II

The CE marked Lumipulse® G CA125-II immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of CA125 in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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C-Peptide Immunoreaction Cartridges
Lumipulse® G C-Peptide

The CE marked Lumipulse® G C-Peptide immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of C-peptide in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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BNP Immunoreaction Cartridges
Lumipulse® G BNP

The CE marked Lumipulse® G BNP immunoreaction cartridges are intended for in vitro diagnostic use with the LUMIPULSE G instruments for the quantitative measurement of human B-type natriuretic peptide (BNP) in human plasma. BNP measurement is highly useful for the diagnosis of heart failure. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme ImmunoAssay) technology with results that are available in up to 35 minutes.
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AMH Immunoreaction Cartridges
Lumipulse® G AMH (anti-Müllerian hormone)

The CE marked Lumipulse® G AMH (anti-Müllerian hormone) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the fully automated quantitative measurement of AMH in specimens based a two-step immunoassay method on the LUMIPULSE G System. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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Aldosterone Immunoreaction Cartridges
Lumipulse® G Aldosterone

The CE marked Lumipulse® G Aldosterone immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of aldosterone in human serum, plasma, or urine. Aldosterone measurement is of help in the diagnosis and treatment of primary aldosteronism.
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AFP-N Immunoreaction Cartridges
Lumipulse® G AFP-N (Alpha-Fetoprotein)

The CE marked Lumipulse® G AFP-N (Alpha-Fetoprotein) immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of alpha-fetoprotein (AFP) in serum or plasma. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.
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25-OH Vitamin D Immunoreaction Cartridges
Lumipulse® G 25-OH Vitamin D

The CE marked Lumipulse® G 25-OH Vitamin D immunoreaction cartridges are intended for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) in human serum or plasma to be used in the assessment of Vitamin D sufficiency.
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BNP Control
Lumipulse® BNP Control

The CE marked Lumipulse® BNP Control are intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analysis of human B-type natriuretic peptide (BNP) on the LUMIPULSE G Systems.
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PCT Control
Lumipulse® B.R.A.H.M.S PCT Control

The CE marked Lumipulse® B.R.A.H.M.S PCT controls are intended for use as an assayed control material to monitor the precision of laboratory testing procedures for the analysis of procalcitonin on the LUMIPULSE G Systems.
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IL-6 LPG Immunoreaction Cartridges
IL-6 (Interleukin) LPG

The IL-6 (Interleukin) LPG immunoreaction cartridges are intended for research use with the LUMIPULSE G system for the quantitative measurement of IL-6 in serum or plasma.
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AMH Control
AMH Control

The CE marked AMH Control is intended for use as an assayed control material to monitor the precision of laboratory testing procedures for the analysis of Anti Müllerian Hormone (AMH) with the LUMIPULSE G System.
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Immunoassay Analyzer
RoboBlot

The CE marked RoboBlot™ is a closed system that offers fully automated processing of INNO-LIA® tests from sample pipetting to strip reading and LiRAS® interpretation, transforming tedious manual work into a completely automated throughput of high testing volumes, ensuring ease of use, chain of custody (Pos ID), and consistent performance.
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Software
LiRAS® for LiPA® HPV (CE Marked)

The LiRAS® for LiPA® HPV (CE Marked) software assists in the interpretation of the HPV genotyping results after scanning of the LiPA strips for HPV genotyping (attached to a LiPA-Scan reading template), or manual entry of the probe reactivities.
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Software
LiRAS® for LiPA® HPV (RUO)

The LiRAS® for LiPA® HPV (RUO) software assists in the interpretation of the HPV genotyping results after scanning of the LiPA strips for HPV genotyping (attached to a LiPA-Scan reading template), or manual entry of the probe reactivities.
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Software
LiRAS® for LiPA® HLA

The CE-Marked LiRAS® for LiPA® HLA software assists in the interpretation of the HLA typing results after scanning of the LiPA strips for HLA (attached to a LiPA-Scan reading template), or manual entry of the probe reactivities.
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Software
LiRAS® for LiPA® HBV (CE-Marked)

The CE-Marked LiRAS® for LiPA® HBV software assists in the objective reading and interpretation of the INNO-LIPA® HBV portfolio.
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Software
LIRAS® for LIPA® HBV (RUO)

The LIRAS® for LIPA® HBV (RUO) software assists in the objective reading and interpretation of the INNO-LIPA® HBV portfolio.
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Software
LiRAS® for LiPA® Cystic Fibrosis

The CE Marked LiRAS® for LiPA® Cystic Fibrosis software assists in the objective reading and interpretation of INNO-LiPA® strips for detection of CFTR mutations and wild-type.
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Software
LiRAS® for LIA® ANA (CE Marked)

The CE Marked LiRAS® for LIA® ANA software assists in the interpretation of LIA ANA test results after scanning of the INNO-LIA® strips (attached to a LIA-Scan™ reading template).
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Software
LiRAS® for LIA® ANA (RUO)

The LiRAS® for LIA® ANA (RUO) software assists in the interpretation of LIA ANA test results scanning of the INNO-LIA® strips (attached to a LIA-Scan™ reading template).
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Software
LiRAS® for Infectious Diseases

The CE marked LiRAS® for Infectious Diseases software assists in the interpretation of the results after scanning of the INNO-LIA strips of the infectious diseases kits (attached to a LIA-Scan™ reading template).
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β-AMYLOID (1-42) Immunoassay - CE Marked
INNOTEST® β-AMYLOID (1-42) - CE Marked

The CE marked INNOTEST® β-AMYLOID (1-42) is a solid-phase enzyme immunoassay for the quantitative determination of β-amyloid (1-42) in human cerebrospinal fluid (CSF). The combined use of CSF-Tau and CSF-β-amyloid (1-42) marker concentrations allows differentiation between Alzheimer’s disease (AD) and normal aging or other neurological diseases such as depression.
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β-AMYLOID (1-42) Immunoassay - RUO
INNOTEST® β-AMYLOID (1-42) - RUO

The INNOTEST® β-AMYLOID (1-42) – RUO is a solid-phase enzyme immunoassay for the quantitative determination of β-amyloid(1-42) in human cerebrospinal fluid (CSF). The combined use of CSF-Tau and CSF-β-amyloid (1-42) marker concentrations allows differentiation between Alzheimer’s disease (AD) and normal aging or other neurological diseases such as depression.
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β-AMYLOID (1-40) Immunoassay - RUO
INNOTEST® β-AMYLOID (1-40) - RUO

The INNOTEST® β-AMYLOID (1-40) – RUO is a solid-phase enzyme immunoassay for the quantitative determination of β-amyloid (1-40) in human cerebrospinal fluid (CSF).
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β-AMYLOID(1-40) Immunoassay CE Marked
INNOTEST® β-AMYLOID(1-40) CE Marked

The CE marked INNOTEST® β-AMYLOID (1-40) is a solid-phase enzyme immunoassay for the quantitative determination of β-amyloid (1-40) in human cerebrospinal fluid (CSF)1,2 in the clinical setting of dementia diagnosis. Values for the 40- and 42-AA-long β-amyloid peptides can be expressed as a β-amyloid ratio, which is of particular use in patients in which an indeterminate CSF biomarker profile (based on 42-AA-long β-amyloid, TAU and Phospho-TAU) is observed.
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PHOSPHO-TAU (181P) Assay CE Marked
INNOTEST® PHOSPHO-TAU (181P) - CE Marked

The CE marked INNOTEST® PHOSPHO-TAU (181P) is a solid-phase enzyme immunoassay for the quantitative determination of phosphorylated Tau (Phospho-Tau (181P)) in human cerebrospinal fluid (CSF). The combined use of CSF-Tau and CSF-β-amyloid (1-42) marker concentrations allows differentiation between Alzheimer’s disease (AD) and normal aging or other neurological diseases such as depression. The discrimination of AD from non-AD types of dementia such as dementia with Lewy Bodies may be further improved using the quantification of CSF-phospho-Tau (181).
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PHOSPHO-TAU (181P) Assay
INNOTEST® PHOSPHO-TAU (181P) (RUO)

The INNOTEST® PHOSPHO-TAU (181P) (RUO) is a solid-phase enzyme immunoassay for the quantitative determination of phosphorylated Tau (Phospho-Tau (181P)) in human cerebrospinal fluid (CSF). The combined use of CSF-Tau and CSF-β-amyloid(1-42) marker concentrations allows differentiation between Alzheimer’s disease (AD) and normal aging or other neurological diseases such as depression. The discrimination of AD from non-AD types of dementia such as dementia with Lewy Bodies may be further improved using the quantification of CSF-phospho-Tau(181).
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hTAU Ag Assay (CE Marked)
INNOTEST® hTAU Ag (CE Marked)

The CE marked INNOTEST® hTAU Ag is a solid-phase enzyme immunoassay for the quantitative determination of Tau protein in human cerebrospinal fluid (CSF). This assay measures the biomarker called total Tau, including the six isoforms (352 to 441 amino acids) from the brain. The combined use of CSF-Tau and CSF-β-amyloid(1-42) marker concentrations allows differentiation between Alzheimer’s disease (AD) and normal aging or other neurological diseases such as depression (1-6).
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hTAU Ag Assay (RUO)
INNOTEST® hTAU Ag

The CE marked INNOTEST® hTAU Ag (RUO) is a solid-phase enzyme immunoassay for the quantitative determination of Tau protein in human cerebrospinal fluid (CSF). This assay measures the biomarker called total Tau, including the six isoforms (352 to 441 amino acids) from the brain. The combined use of CSF-Tau and CSF-β-amyloid (1-42) marker concentrations allows differentiation between Alzheimer’s disease (AD) and normal aging or other neurological diseases such as depression (1-6).
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hPLAP Assay
INNOTEST® hPLAP

The CE marked INNOTEST® hPLAP is an enzyme immunoassay based on a unique monoclonal antibody for the quantitative determination of human placental alkaline phosphatase (hPLAP) in serum and heparinized plasma. hPLAP (human placental alkaline phosphatase) is a marker for diagnosis and monitoring of seminomas.
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HIV p24 Antigen Test
INNOTEST® HIV Antigen mAb

The CE marked INNOTEST® HIV Antigen mAb is an enzyme immunoassay for the qualitative detection of HIV p24 antigen in human serum, plasma, and cell culture supernatant. The kit contains reagents for confirmation of HIV p24 antigens in repeatedly reactive samples.
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HCV Immunoassay
INNOTEST® HCV Ab IV

The CE marked INNOTEST® HCV Ab IV is an enzyme immunoassay for the detection of antibodies to human hepatitis C virus (HCV) in human serum or plasma and in which the wells of polystyrene microplate strips are coated with a mixture of HCV antigens. This 4th generation assay has increased sensitivity due to the use of antigens with improved reactivity, derived from the most prevalent HCV genotypes. Antibodies reactive with the core (2 different epitope clusters), NS3, NS4A, NS4B, and NS5A regions of HCV genotypes 1a and 1b, as well as the NS3 and NS4 regions of HCV genotypes 2 and 3a can be detected. The assay is easy to use with a sample addition monitoring system, color-coded reagents, and sample volume of 20 µL.
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MYCOBACTERIA Assay
INNO-LiPA® MYCOBACTERIA v2

The CE marked INNO-LiPA® MYCOBACTERIA v2 is a line probe assay for the simultaneous detection and identification of the genus Mycobacterium and 16 different mycobacterial species on one strip. The test is based on the nucleotide differences in the 16S-23S rRNA spacer region and can be performed starting from either liquid or solid culture.
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HLA-DRB1 Assay
INNO-LiPA® HLA-DRB1 Plus

The CE marked INNO-LiPA® HLA-DRB1 Plus is a line probe assay for the molecular typing of human leukocyte antigen (HLA) DRB1 alleles at allele group level (DRB1*01–DRB1*16). It detects all known alleles of HLA-DRB1 (except for DRB1*1130) with one amplification and one strip.
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HLA-DQB1 Assay
INNO-LiPA® HLA-DQB1 Update

The CE marked INNO-LiPA® HLA-DQB1 Update is a line probe assay for the molecular typing of human leukocyte antigen (HLA) DQB1 alleles at allelic level (DQB1*02–DQB1*06).
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HLA-DQA1 Assay
INNO-LiPA® HLA-DQA1

The CE marked INNO-LiPA® HLA-DQA1 is a line probe assay for the molecular typing of human leukocyte antigen (HLA) DQA1 alleles at allelic level (DQA1*01–DQA1*06).
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HLA-C Assay
INNO-LiPA® HLA-C

The CE marked INNO-LiPA® HLA-C is a line probe assay for the molecular typing of human leukocyte antigen (HLA) C alleles at allele group level (Cw*01 – Cw*18).
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HLA-B Assay
INNO-LiPA® HLA-B Update Plus

The CE marked INNO-LiPA® HLA-B Update Plus is a line probe assay for the molecular typing of human leukocyte antigen (HLA) B alleles at allele group level (B*07 – B*83). Bw4/Bw6 ambiguities can be resolved by an additional Bw4-specific amplification and hybridization on one strip.
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HLA-A Assay
INNO-LiPA® HLA-A Update

The CE marked INNO-LiPA® HLA-A Update is a line probe assay for the molecular typing of human leukocyte antigen (HLA) A alleles at allele group level (A*01–A*80).
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HBV Multi-DR Assay (CE Marked)
INNO-LIPA® HBV Multi-DR (CE Marked)

The CE marked INNO-LIPA® HBV Multi-DR is a line probe assay for simultaneous detection of hepatitis B virus wild-type motif, lamivudine, telbivudine, emtricitabine, adefovir, and entecavir resistance-associated mutations.
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HBV Multi-DR Assay
INNO-LiPA® HBV Genotyping (RUO)

The INNO-LIPA® HBV Multi-DR (RUO) is a line probe assay for simultaneous detection of hepatitis B virus wild-type motif, lamivudine, telbivudine, emtricitabine, adefovir, and entecavir resistance-associated mutations.
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HBV Genotyping Assay
INNO-LiPA® HBV Genotyping

The CE marked INNO-LiPA® HBV Genotyping is a line probe assay designed to identify hepatitis B virus genotypes A to H by the detection of type-specific sequences in the HBV polymerase gene domain B to C.
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CFTR iage Line Probe Assay
INNO-LiPA® CFTR iage

The CE marked INNO-LiPA® CFTR iage is a line probe assay, intended for the simultaneous in vitro detection and identification of 88 human Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations and their wild type sequence in human whole blood, dried blood spots or buccal brushes. This qualitative genotyping test provides information for carrier testing in adults of reproductive age, can be used as an aid in newborn screening as well as in confirmatory diagnostic testing. The assay uses amplification reagents intended for the nucleic acid multiplex amplification of 40 regions of the CFTR gene (regions for some mutations are combined) in only one reaction. The INNO-LiPA CFTR iage approach provides a multiparameter screening test for CFTR gene mutations and discriminates between healthy normal individuals, healthy carriers, and affected patients.
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CFTR 19 Line Probe Assay
INNO-LiPA® CFTR 19

The CE marked INNO-LiPA® CFTR 19 is a multiparameter line probe assay, based on the reverse hybridization principle, for the simultaneous detection and identification of 35 cystic fibrosis-related mutations and their wild-type sequences in human whole blood, dried blood spots, and buccal brush samples. In addition, probes for the identification of the Tn polymorphism within intron 8 are included.
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CFTR 17+Tn Line Probe Assay
INNO-LiPA® CFTR 17+Tn Update

The CE marked INNO-LiPA® CFTR 17+Tn Update is a multiparameter line probe assay, based on the reverse hybridization principle, for the simultaneous detection and identification of 36 Cystic Fibrosis-related mutations and their wild-type sequences in human whole blood, dried blood spots, and buccal brush samples. In addition, probes for the identification of the Tn polymorphism within intron 8 are included.
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CFTR Italian Regional Assay
INNO-LiPA® CFTR Italian Regional

The CE marked INNO-LiPA® CFTR Italian Regional is a multiparameter line probe assay, based on the reverse hybridization principle, for the simultaneous detection and identification of 21 Italian Cystic Fibrosis-related mutations and their wild-type sequences in human whole blood, dried blood spots and buccal brush samples. This product is in addition to the INNO-LiPA CFTR 19 and INNO-LiPA CFTR 17+Tn Update kits that test for the most common mutations worldwide.
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CFTR Line Probe Assay
INNO-LIPA® CFTR Deletions+6

The CE marked INNO-LIPA® CFTR Deletions+6 is a multiparameter line probe assay, based on the reverse hybridization principle, for the simultaneous detection and identification of 8 large rearrangements and 6 mutations and their wild-type sequences in human whole blood, dried blood spots, and buccal brush samples. For the detection and identification of all ACMG mutations the INNO-LiPA CFTR 19 and INNO-LiPA CFTR 17+Tn Update kits are both required to be tested (testing for 35 mutations, one polymorphism and three Tn variants).
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Syphilis Immunoassay (CE marked)
INNO-LIA® Syphilis Score (CE marked)

The CE marked INNO-LIA® Syphilis Score is a line immunoassay to confirm the presence of antibodies against Treponema pallidum in human serum or plasma.
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Syphilis Immunoassay (RUO)
INNO-LIA® Syphilis Score (RUO)

The INNO-LIA® Syphilis Score is a line immunoassay for research use only to confirm the presence of antibodies against Treponema pallidum in human serum or plasma.
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HTLV-I/II Immunoassay
INNO-LIA® HTLV I/II Score

The CE marked INNO-LIA® HTLV I/II Score is a line immunoassay for the confirmation and discrimination of antibodies to Human T-cell Lymphotrophic Virus type I (HTLV-I) and type II (HTLV-II) in human serum and plasma. The assay uses well-defined antigens derived from HTLV I and HTLV II immunodominant proteins.
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HCV Immuonassay
INNO-LIA® HCV Score

The CE marked INNO-LIA® HCV Score is a line immunoassay for the detection of antibodies to human hepatitis C virus in human serum and plasma. It is intended for use as a supplementary test on human serum or plasma specimens found to be reactive in an anti-HCV screening procedure. The INNO-LIA HCV Score assay utilizes well-defined antigens derived from HCV immunodominant proteins from the core region, the E2 hypervariable region (HVR), the NS3 helicase region and the NS4A, NS4B and NS5A regions. The antigens used are either recombinant proteins or synthetic peptides, highly purified, and fixed on a nylon membrane.
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Immunoassay Test
INNO-LIA® ANA Update

The CE marked INNO-LIA® ANA Update is a line immunoassay for the detection and identification of autoantibodies against nuclear and cytoplasmic antigens in human serum, with the ability to identify 13 autoantigens in one run.
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Treponema Pallidum Reagent
ESPLINE® TP

The CE marked ESPLINE® TP reagent is based on the principle of immuno-chromatography for detection of antibodies to Treponema pallidum (TP) in serum or plasma samples. The test kit employs two recombinant antigens that are considered to be the main antigens of TP. These recombinant antigens are fixed to a membrane in the test part of the cassette. An enzyme-labeled antigen pad, a substrate pad, and a developing solution are also included in the cassette.
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SARS-CoV-2 Assay
ESPLINE® SARS-CoV-2

The CE marked ESPLINE® SARS-CoV-2 is a cassette-style immunochromatographic assay for in vitro diagnostic (IVD) use for the detection of SARS-CoV-2 antigen directly from nasopharyngeal swab fluid. It can detect SARS-CoV-2 within 30 minutes using a simple procedure without any special instruments and is intended for use as an aid in the diagnosis of SARS-CoV-2 infection.
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Reagent
ESPLINE® Influenza A&B-N

The CE marked ESPLINE® Influenza A&B-N is a cassette-style reagent for detection of influenza A & B virus antigens using a simple procedure without any special instrument. It uses immuno-chromatography technology based on the principle of enzyme immunoassay. Both the influenza A virus antigen and influenza B virus antigen from nasal swab fluid, pharyngeal swab fluid, and nasal aspirate fluid can be detected by a single test.
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Real-Time PCR Detection System
PowerGene 9600 Plus

The CE marked PowerGene 9600 Plus Real-Time PCR detection system features a specially-made Ferrotec Peltier, advanced fiber optic technology, a new global wide-range power supply, the unique patented block dissipation technology and bottom detection mode, that help it provide better heating/cooling rate, temperature accuracy, uniformity and stability. The design of 5 channel detection covers the whole fluorescence detection wavelength and the PowerGene 9600 Plus has a high speed of dual-color scanning. The newly-designed automatic hot-lid without manual operation ensures constant pressure for various tube heights.
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HPV Genotyping Assay
AmpFire® HPV Screening 16/18/HR

The CE marked AmpFire® HPV Screening 16/18/HR kit is intended for fast, simple, and accurate qualitative detection and identification of 15 High-Risk HPV types with simultaneous genotyping of HPV16 and 18 in one tube.
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HPV Genotyping Assay
AmpFire® HPV High Risk Genotyping

The CE marked AmpFire® HPV High Risk Genotyping kit is intended for fast, simple, and accurate qualitative detection and identification of 15 High-Risk HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, and 68.
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COVID-19 Test
iAMP COVID-19 Detection Kit

The CE marked iAMP COVID-19 Detection Kit is designed for the qualitative nucleic acid detection of SARS-CoV-2 (COVID-19) on naso- or oropharyngeal swabs without pre-treatment. Using isothermal amplification with real time fluorescence detection, the kit requires limited hands-on time and delivers fast sample-to-result within 75 to 90 minutes only.
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PRUEBA DE ANTICUERPOS SARS-COV-2
Lumipulse G SARS-CoV-2 Ag

La prueba Lumipulse G SARS-CoV-2 Ag fue diseñada para uso diagnóstico in vitro (IVD) con el sistema Lumipulse G para la detección y medición cuantitativa del antígeno SARS-CoV-2 en hisopados nasofaríngeos o saliva humana.
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ENSAYO DE GENOTIPIFICACIÓN CTFR
INNO-LiPA CFTR Extra

El análisis CFTR Extra INNO-LiPA®, con marca CE, es un ensayo de sonda de línea, destinado a la detección e identificación simultánea in vitro de 18 mutaciones del gen del regulador de conductancia transmembrana de la fibrosis quística (CFTR) humana.
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HE4 Immunoreaction Cartridges
Lumipulse G HE4 (Human epididymis protein 4)

The CE marked Lumipulse G HE4 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for in vitro diagnostics (IVD) use for the quantitative measurement of HE4 (Human epididymis protein 4) in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G system. The assay is the first new biomarker in 30 years for ovarian cancer management and utilizes proven CLEIA technology to deliver results in up to 35 minutes.
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PRUEBA DE INMUNOENSAYO
INNO-LiPA HPV Genotyping Extra II (20T)

La línea de inmunoensayos, INNO-LiPA HPV Genotyping Extra II (20T), está destinada a la identificación individual de 32 genotipos del VPH. Viene con una mezcla maestra fácil y lista para usar, junto con la ADN polimerasa Taq.
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Immunoassay Test
INNO-LIA HIV I/II Score (20T)

The CE marked INNO-LIA® HIV I/II Score immunoblot assay is intended for the confirmation and discrimination of antibodies to HIV-1, HIV-1 group O and HIV-2 in human serum and plasma. The INNO-LIA HIV I/II Score test contains recombinant proteins and synthetic peptides from HIV-1 and HIV-2 as well as a synthetic peptide from HIV-1 group O. These carefully selected antigens are coated at optimal concentrations as discrete lines on a nylon strip with plastic backing.
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Ensayo Para la PCT
Lumipulse G B•R•A•H•M•S PCT Assay

El Lumipulse G BRAHMS PCT es un análisis CLEIA para la determinación cuantitativa de PCT en suero y plasma humanos. Ofrece resultados en 35 minutos, por lo que es ideal para pacientes con infección del tracto respiratorio inferior sospechada o confirmada.
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Immunoassay Analyzer
TENDIGO

The TENDIGO immunoassay analyzer turns daily manual work into automation for low throughput testing volumes with validated INNO-LIA and INNO-LIPA assay protocols on board and open protocol programming. Other features include easy operation, minimum hands-on time, walkaway principle, and dry heating on board for fast and accurate processing.
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HTLV-I/II Immunoreaction Cartridges
Lumipulse G HTLV-I/II

The CE marked Lumipulse G HTLV-I/II immunoreaction cartridges is meant for in vitro diagnostic use with the LUMIPULSE G System for qualitative detection of antibody to HTLV-I and HTLV-II in human serum or plasma for screening of HTLV-I/II viral infection. The assay utilizes proven CLEIA (ChemiLuminescent Enzyme ImmunoAssay) technology with results that are available in up to 35 minutes.
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CLEIA Analyzer
LUMIPULSE G600 II

The CE marked LUMIPULSE G600II, the latest member of the LUMIPULSE G series chemiluminescent enzyme immunoassay (CLEIA) analyzers from Fujirebio, uses a unique mono test cartridge concept and features a constant throughput of 60 tests per hour. The compact and robust benchtop analyzer provides a perfect fit in hospitals and clinical laboratories aiming for personalized workflow solutions without compromising testing quality, offering outstanding flexibility and easy handling.
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ANALIZADOR CLEIA
LUMIPULSE G1200

El LUMIPULSE G1200 utiliza un concepto de cartucho de prueba mono y realiza un rendimiento real de 120 pruebas por hora. El analizador proporciona una excelente flexibilidad y fácil manejo en hospitales y laboratorios clínicos.
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