DIAZYME LABORATORIES

DIAZYME LABORATORIES

Diazyme develops diagnostic reagents using its proprietary enzyme technologies that can be used on most automated chemistry analyzers in user-friendly formats. Its product range includes test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, and electrolytes.
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Covid-19 DIAZYME LABORATORIES

Laboratorio clínico

SARS-CoV2 Antibody Test
DZ-Lite SARS-CoV-2 IgG CLIA Kit

The Diazyme DZ-Lite SARS-CoV-2 IgG CLIA kit is for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma to aid identifying individuals with an adaptive immune response to SARS-CoV-2, indicating a recent or prior infection. The test runs on the fully automated DZ-Lite 3000 Plus Chemiluminescence Analyzer and is an Emergency Use Authorization (EUA) test authorized by the US FDA for use by authorized laboratories.
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SARS-CoV2 Antibody Test
DZ-Lite SARS-CoV-2 IgM CLIA Kit

The Diazyme DZ-Lite SARS-CoV-2 IgM CLIA kit is for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum and plasma (potassium EDTA, disodium EDTA and lithium heparin) to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The test runs on the fully automated DZ-Lite 3000 Plus Chemiluminescence Analyzer and is an Emergency Use Authorization (EUA) test authorized by the US FDA for use by authorized laboratories.
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SARS-CoV-2 PCR Test
Macurra SARS-CoV-2 PCR Kit

The Macurra SARS-CoV-2 PCR Kit is a qualitative assay that allows the detection of nucleic acids in samples from patients who meet COVID-19 (coronavirus) clinical and/or epidemiological criteria. It is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories.
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Actualizado

H-FABP Assay
Heart-Type Fatty Acid-Binding Protein Assay

The Diazyme Heart-Type Fatty Acid-Binding Protein (H-FABP) Assay is intended for the determination of heart-type fatty acid-binding protein concentration in serum or lithium-heparin plasma by latex-enhanced immunoturbidimetric method. The convenient dual-vial liquid stable assay is ideal for analyzers that require two part reagent systems using a fast, accurate, and cost-effective method.
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L-Homocysteine Assay
Homocysteine (HCY) 2 Reagent Enzymatic Assay

The Homocysteine (HCY) 2 Reagent Enzymatic Assay measures total L-homocysteine in serum/plasma, assisting in diagnosing hyperhomocysteinemia. It features a dual-vial liquid-stable format, ensuring fast, interference-free results. With a linear range of 3-50 μmol/L and excellent HPLC correlation, it is ideal for cardiovascular risk assessment.
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Oxidized LDL Assay
Diazyme OxLDL Assay

The Diazyme OxLDL Assay quantifies oxidized LDL in serum or plasma, aiding in lipid disorder and cardiovascular disease diagnosis. Unlike traditional LDL tests, it detects oxidized lysine residues on apoB100, offering greater specificity. It is fully automated and compatible with clinical chemistry analyzers.
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Laboratorio clínico

H-FABP Assay
Heart-Type Fatty Acid-Binding Protein Assay

The Diazyme Heart-Type Fatty Acid-Binding Protein (H-FABP) Assay is intended for the determination of heart-type fatty acid-binding protein concentration in serum or lithium-heparin plasma by latex-enhanced immunoturbidimetric method. The convenient dual-vial liquid stable assay is ideal for analyzers that require two part reagent systems using a fast, accurate, and cost-effective method.
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L-Homocysteine Assay
Homocysteine (HCY) 2 Reagent Enzymatic Assay

The Homocysteine (HCY) 2 Reagent Enzymatic Assay measures total L-homocysteine in serum/plasma, assisting in diagnosing hyperhomocysteinemia. It features a dual-vial liquid-stable format, ensuring fast, interference-free results. With a linear range of 3-50 μmol/L and excellent HPLC correlation, it is ideal for cardiovascular risk assessment.
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Oxidized LDL Assay
Diazyme OxLDL Assay

The Diazyme OxLDL Assay quantifies oxidized LDL in serum or plasma, aiding in lipid disorder and cardiovascular disease diagnosis. Unlike traditional LDL tests, it detects oxidized lysine residues on apoB100, offering greater specificity. It is fully automated and compatible with clinical chemistry analyzers.
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CEA Assay
Carcinoembryonic Antigen Assay

The Diazyme Carcinoembryonic Antigen (CEA) Assay is a diagnostic tool used for detecting elevated levels of CEA, a tumor marker associated with various cancers, including colorectal, lung, and breast cancer. This assay provides high sensitivity and accuracy, supporting early detection, monitoring, and management of cancerous conditions.
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AFP Assay
α-Fetoprotein (AFP) Assay

The Diazyme α-Fetoprotein (AFP) Assay is designed for the quantitative measurement of AFP in human serum. This assay is a vital tool for diagnosing liver cancer and monitoring patients with cirrhosis or hepatocellular carcinoma. It offers high sensitivity and specificity, facilitating early detection and management of these conditions.
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sdLDL Assay
Small Dense Low-Density Lipoprotein Cholesterol Assay

The Diazyme Small Dense Low-Density Lipoprotein Cholesterol (sdLDL) Assay is used to measure the levels of sdLDL cholesterol in human serum. This assay provides critical insights into cardiovascular risk by identifying atherogenic cholesterol particles linked to heart disease. It offers high sensitivity and accuracy for precise lipid profiling and patient assessment.
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HDL3 Assay
High-Density Lipoprotein III Assay

The Diazyme High-Density Lipoprotein III (HDL3) Assay measures HDL3 cholesterol levels, a key fraction of high-density lipoprotein associated with cardiovascular health. This assay helps assess atherosclerotic risk and supports the evaluation of lipid profiles. It is designed for high sensitivity and accuracy, aiding in the detection of cardiovascular disease risk.
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Apolipoprotein A-I Assay
Apo A-I Assay

The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative determination of Apolipoprotein A-I (Apo A-I) in serum. It can be used as an aid for assessing the risk of coronary artery disease.
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Lipoprotein Assay
DZ-Lite OxPL Lipoprotein Assay

The DZ-Lite OxPL Lipoprotein Assay kit is a chemiluminescent immunoassay intended for the in vitro quantitative measurement of oxidized phospholipids of low-density lipoproteins in human serum. It can be used as an aid in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
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1,5-anhydroglucitol (1,5-AG) Assay
1,5-anhydroglucitol (1,5-AG) Assay

The Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-AG Assay is meant for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes.
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Fibrinogen Assay
Fibrinogen Assay

The Diazyme Fibrinogen Assay is intended for the quantitative determination of fibrinogen levels in citrated human plasma. This highly sensitive liquid stable immunoturbidimetric test kit is designed to work on most open clinical chemistry analyzers to provide rapid results with reduced reagent cost.
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Ferritin Assay
Ferritin Assay

The Diazyme Ferritin Assay is for the quantitative determination of ferritin in human serum, K2EDTA plasma, and lithium heparin plasma on the Hitachi 917 analyzer. This latex-enhanced immunoturbidimetric assay is intended for in vitro diagnostic use only.
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Calprotectin Assay – Gastro-Health Biomarker
Diazyme Calprotectin Assay

Diazyme’s Calprotectin Assay is a highly sensitive, specific, latex-enhanced immunoassay for quantitative fecal calprotectin measurement. Its liquid-stable format requires no reagent preparation, delivering results in just 10 minutes. Designed for clinical chemistry analyzers, it offers rapid, reliable diagnostics. CE marked and 510(k) cleared, it’s an essential tool for gastrointestinal health assessment, ensuring accurate and timely patient care.
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Kappa FLC Assay
Human Kappa (κ) Free Light Chain Assay

The Diazyme Human Kappa (κ) Free Light Chain Assay is a latex particle-enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings.
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Lithium Assay
Lithium Enzymatic Assay Kit

Diazyme's Lithium Enzymatic Assay kit is intended for the quantitative in vitro determination of lithium in human serum. Lithium measurements are carried out essentially to ensure that proper drug dosage is administered in the treatment of patients suffering from bipolar disorder and to avoid toxicity.
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PLAC Test for Lp-PLA2 Activity
PLAC Lp-PLA2 Activity Assay

The PLAC Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. It is the only blood test cleared by the FDA to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting the risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
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5'-NT Assay Kit
5'-Nucleotidase Assay

Diazyme's 5'-Nucleotidase (5'-NT) assay kit is intended for the determination of 5'-NT activity in human serum samples. 5’-NT is a specific marker for assessing liver disease progression and its diagnostic value has been shown to be superior to other liver enzymes, especially in cases of liver metastasis.
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Potassium Assay
Potassium Assay

Diazyme's Potassium Assay is intended for the in vitro quantitative determination of potassium in human serum. Measurements obtained by this assay are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
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RBP Assay
Retinol Binding Protein (RBP) Assay

Diazyme's Retinol Binding Protein (RBP) assay is a dual liquid stable reagent system that provides reliable results and has within-run precision values of less than 1.2% and a total precision value of less than 3.2%. The method requires only 3 μL of sample, completed in less than 10 minutes, and has an excellent correlation with existing commercial products.
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HDL-Cholesterol Assay
HDL-Cholesterol Assay

Diazyme's HDL-Cholesterol Assay is a direct dual liquid stable reagent system that utilizes its proprietary PVSPEGME coupled technology which provides outstanding performance. It is available in convenient instrument-specific packaging options including Roche Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX, LX, and DXC.
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Creatinine Liquid Reagents Assay
Creatinine Liquid Reagents Assay

Diazyme's Creatinine Liquid Reagents Assay offers significant advantages compared to the conventional Jaffe method for Creatinine which is caustic (picric acid) and can stain analyzer tubing and cuvettes. Diazyme's enzymatic method is non-caustic, non-staining, and has no costly hazardous shipping requirements. Packaged for optimal operator convenience, reagent transfer can be eliminated for most chemistry systems with instrument-specific packaging options.
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Apolipoprotein B Assay
Apolipoprotein B (Apo B) Assay

The Apolipoprotein B Assay is intended for the quantitative in vitro determination of Apolipoprotein B (Apo B) in serum and has a linear range of 3.6 – 240 mg/dL with good correlation with existing FDA-approved product with r2 values >0.99. It can be used as an aid for assessing the risk of coronary artery disease.
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Lipoprotein (a) Assay
Lipoprotein (a) Assay

The Diazyme Lipoprotein (a) Assay is intended as a latex particle-enhanced immunoturbidimetric assay for the in vitro quantitative determination of Lp(a) concentration in human serum or plasma on clinical chemistry systems. The dual vial, liquid stable reagent system provides reliable results and requires only 6 μL of serum sample with testing completed in less than 10 minutes.
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Procalcitonin Assay
Procalcitonin (PCT) Assay

Diazyme Procalcitonin (PCT) Assay is a latex particle-enhanced immunoturbidimetric method intended for the quantitative determination of PCT in human serum, EDTA, or lithium heparin plasma. Diazyme’s PCT methodology utilizes multiple monoclonal antibodies for enhanced assay sensitivity and specificity.
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Liquid Stable Enzymatic Sodium Assay
Sodium Assay

Diazyme Liquid Stable Enzymatic Sodium Assay is intended for the quantitative in vitro determination of sodium in serum. The assay has a good correlation with the ISE method and has a linear method between sodium concentrations of 80 and 180 mmole/L (184 and 414 mg/dL).
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Total Bile Acids Assay
Total Bile Acids (TBA) Assay

Diazyme Total Bile Acids Assay Kit is intended for the in vitro quantitative determination of total bile acids (TBA) in human serum. The liquid stable system is ready to use for both manual methods and is adaptable for many automated chemistry analyzers.
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Lipase Assay
Lipase Assay

The Diazyme Lipase assay in conjunction with lipase assay calibrator set is intended for the in vitro quantitative determination of lipase in serum or plasma. It provides an extended linear range up to 250 U/L with virtually no interferences from triglyceride 300 mg/dL, hemoglobin 150 mg/dL, and bilirubin up to 20 mg/dL, and has excellent inter-assay and intra-assay precision.
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Liquid Stable Enzymatic Sodium Assay
Diazyme Sodium Enzymatic Assay

Diazyme Liquid Stable Enzymatic Sodium Assay is intended for the quantitative in vitro determination of sodium in serum. The obtained measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
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REACTIVO DE HOMOCISTEÍNA
Homocysteine Enzymatic Assay

El kit de prueba enzimática de homocisteína está diseñado para la determinación cuantitativa de la L-homocisteína total en suero o plasma, lo que ayuda en el diagnóstico y tratamiento de la sospecha de hiperhomocisteinemia y homocistinuria.
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25-OH-Vitamin D Assay
EZ Vitamin D Assay

The Diazyme EZ Vitamin D assay is intended for use in clinical laboratories for the quantitative determination of 25-OH vitamin D (vitamin D) in human serum and plasma, using automated chemistry analyzers. The measurement of vitamin D is used for the assessment of the vitamin D sufficiency and the assay is intended for in vitro diagnostic use only.
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Myoglobin Assay
Myoglobin Assay

The Diazyme Myoglobin Assay is intended for the quantitative determination of myoglobin in human serum and plasma. Based on the latex enhanced immunoturbidimetric method, the assay is formulated in a convenient dual liquid stable format, and is highly cost effective.
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Low Density Lipoprotein Cholesterol Test
LDL-Cholesterol Assay

The Diazyme LDL-Cholesterol Assay is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease.
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Creatinine Liquid Reagents Assay
Creatinine Assay (Enzymatic)

Diazyme's Creatinine Liquid Reagents Assay, in conjunction with Diazyme's Creatinine Calibrator, is intended for the quantitative determination of creatinine in serum and urine. It offers significant advantages compared to the conventional Jaffe method for Creatinine which is caustic (picric acid) and can stain analyzer tubing and cuvettes.
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D-Dimer Immunoturbidimetric Test
D-Dimer Assay

Diazyme's D-Dimer Assay is intended for the quantitative determination of fibrinogen/fibrin degradation products (D-Dimer) in human plasma as an aid in detecting the presence of intravascular coagulation and fibrinolysis. The highly sensitive liquid stable latex enhanced immunoturbidimetric test kit is designed to work on most open clinical chemistry analyzers and provide rapid results with reduced reagent cost.
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FLC Assay
Human Lambda Free Light Chain Assay

Diazyme's Human Lambda Free Light Chain (FLC) assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on Hitachi 917 analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings.
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Cardiac Troponin Immunoturbidimetric Test
Cardiac Troponin I Assay

Diazyme's Cardiac Troponin I Assay is a highly sensitive liquid stable latex enhanced immunoturbidimetric test kit that provides rapid reliable results at a low reagent cost and is designed to work on most open clinical chemistry analyzers. The assay offers reliable results across the entirely clinical important reportable range and is convenient, fast and an accurate alternative to more expensive methods that require a dedicated immunochemistry.
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ANALIZADOR DE QUIMIOLUMINISCENCIA
DZ-Lite 3000 Plus

El analizador de quimioluminiscencia Diazyme DZ-Lite 3000 Plus es un sistema fácil de usar con aprobación 510k de la FDA que determina el modo de reacción y determina la sensibilidad, exactitud y precisión de los reactivos.
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SARS-CoV-2 PCR Test
Macurra SARS-CoV-2 PCR Kit

The Macurra SARS-CoV-2 PCR Kit is a qualitative assay that allows the detection of nucleic acids in samples from patients who meet COVID-19 (coronavirus) clinical and/or epidemiological criteria. It is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories.
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SARS-CoV2 Antibody Test
DZ-Lite SARS-CoV-2 IgM CLIA Kit

The Diazyme DZ-Lite SARS-CoV-2 IgM CLIA kit is for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum and plasma (potassium EDTA, disodium EDTA and lithium heparin) to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The test runs on the fully automated DZ-Lite 3000 Plus Chemiluminescence Analyzer and is an Emergency Use Authorization (EUA) test authorized by the US FDA for use by authorized laboratories.
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SARS-CoV2 Antibody Test
DZ-Lite SARS-CoV-2 IgG CLIA Kit

The Diazyme DZ-Lite SARS-CoV-2 IgG CLIA kit is for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma to aid identifying individuals with an adaptive immune response to SARS-CoV-2, indicating a recent or prior infection. The test runs on the fully automated DZ-Lite 3000 Plus Chemiluminescence Analyzer and is an Emergency Use Authorization (EUA) test authorized by the US FDA for use by authorized laboratories.
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Glycated Serum Protein Assay
GlycoGap

The GlycoGap Glycated Serum Protein Assay in conjunction with Diazyme Glycated Serum Protein single calibrator is intended for the quantitative determination of glycated serum proteins (GSP; glycated albumins; fructosamine) in serum. The enzymatic assay for glycated serum protein provides improved specificity and reliability as compared to conventional NBT-based methods, and is highly precise with a total CV ≤ 1.3%.
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ENSAYO PARA HBA1C
Direct HbA1c Assay

El kit de prueba de Ensayo directo de HbA1c (enzimático, lisis a bordo) está diseñado para ser usado en la determinación cuantitativa de HbA1c estable en muestras de sangre total venosa con aplicación de la lisis de sangre a bordo en el laboratorio clínico.
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Lp-PLA2 Activity Test
PLAC Test

The PLAC Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. It is the only blood test cleared by the FDA to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
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ANALIZADOR DE QUÍMICA CLÍNICA
DZ-Lite c270

El DZ-Lite c270 es un analizador de química clínica de sobremesa completamente automatizado con un rendimiento de hasta 270 pruebas/hora. Es compacto, con una interfaz fácil de usar y admite ensayos de 1 y 2 reactivos y de 3 y 4 reactivos.
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Vitamin D assay
25-OH Vitamin D Assay

Diazyme's 25-OH Vitamin D assay is intended for the quantitative determination of 25-(OH) D levels in serum or plasma on automated chemistry analyzers and for the assessment of Vitamin D sufficiency. It contains one sample diluent and three liquid stable reagents and calibrator set, and requires a minimal sample of only 20 μL to deliver the first results in 15-19 minutes.
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