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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

Clinical Laboratory

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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About 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.

Recently updated

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.
More details

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.
More details

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.
More details

Clinical Laboratory

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.
More details

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.
More details

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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HbA1c Assay
Direct HbA1c Assay

The Direct HbA1c Assay (Enzymatic, On-Board Lysis) test kit is intended for use in the quantitative determination of stable HbA1c in venous whole blood samples with on-board blood lysis application in a clinical laboratory. The unique single channel assay is ideal for labs requiring a high throughput HbA1c method with no off-line pretreatment steps and delivers a high throughput using a patented single channel method which eliminates the need for a dedicated channel for total hemoglobin, thereby improving assay turnaround time.
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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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Clinical Chemistry Analyzer
DZ-Lite c270

The DZ-Lite c270 is a fully automated, benchtop clinical chemistry analyzer with a throughput of upto 270 tests/hour and an innovative assay menu. The compact instrument has a user-friendly interface and supports both one & two-reagent and three & four-reagent assay.
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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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