USA: 510(k)

Diazyme's Lipase Assay 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. Diazyme's Lipase Assay has excellent inter-assay and intra-assay..…

Diazyme's Lipoprotein (a) is a dual vial, liquid stable reagent system which provides reliable results. The assay method requires only 6 μL of serum sample and is completed in less than 10 minutes. Description Catalog Number Packaging ...

Diazyme's HDL-Cholesterol Assay is a direct dual liquid stable reagent system. Convenient instrument specific packaging options including Roche™ Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX, LX and DXC. The assay utiliz…

The assay utilizes Diazyme's proprietary PVSPEGME coupled technology which provides outstanding performance. The assay features a linear range of up to 250 mg/dL, intra and inter %CV values < 5.0 % and less than 10% interference from triglycerides…

Diazyme's 5'-Nucleotidase Assay is linear from 0 - 300 U/L (R² >0.99) with intra-assay CV% of < 2% and an inter-assay CV% of ≤ 4%. 5'-Nucleotidase assay is not affected by interfering substances such as serum bilirubin up to 40 mg/dL,..…

Diazyme's CO2 Enzymatic Assay is a single vial liquid stable reagent system which has a neutral pH, minimizing the effect of CO2 absorption from the air. In addition to a highly stable NADH analog as a co-factor the reagent maintains integrity by...…

Diazyme's Lithium Assay provides a convenient, stable, non-caustic low cost alternative to expensive ISE and highly caustic alkaline Lithium methods. Diazyme's Lithium Assay demonstrates an excellent correlation with ISE methods and offers excellent.…

Diazyme's Sodium Assay has 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). The assay has CV's% of <2% with a correlation coefficient of 0.98, slope of 1.05…

Diazyme's Potassium Assay has an outstanding linearity range from 2.0 mmol/L – 8.0 mmol/L. Diazyme's Potassium Assay offers excellent precision CV% of  <2%. A comparison study showed that the assay has good correlation with existing ISE…

Diazyme's enzymatic assay for glycated serum protein provides improved specificity and reliability compared to conventional NBT-based methods. The assay is highly precise with a total CV ≤ 1.3%. The assay offers extensive linearity up to 1354...

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...

The Diazyme Total Bile Acids (TBA) Assay is a liquid stable system, ready to use for both manual methods and is adaptable for many automated chemistry analyzers. The assay has excellent sensitivity with a linear range from 0 - 180 μM. Diazyme's...…

Diazyme's EZ Vitamin D Assay is the first and only 2-reagent, latex enhanced immunoturbidimetric assay for use on general clinical chemistry analyzers. This new Vitamin D assay allows many clinical laboratories to run the EZ Vitamin D test in house, …

Diazyme's PLAC® Test 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...