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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.

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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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Clinical Laboratory

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.
More details

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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Homocysteine Reagent
Homocysteine Enzymatic Assay

The Diazyme Homocysteine Enzymatic Assay kit is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. The assay can assist in diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
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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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Chemiluminescence Analyzer
DZ-Lite 3000 Plus

The Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer is an FDA 510k cleared user-friendly system that determines reaction mode and determines sensitivity, accuracy and precision of reagents. It uses magnetic microbeads for its separation technology that shortens reaction time, enhances sensitivity, and reduces inter or intra-assay discrepancies.
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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.
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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