USA: 510(k)

Diazyme's Apo B Assay has a linear range of 3.6 – 240 mg/dL with good correlation with existing FDA approved product with r2 values >0.99. The Diazyme Apo B Assay is not interfered by the following...

Diazyme's Apo A-I Assay kit has a linear range of 1.44 - 250 mg/dL and good correlation with an existing FDA approved product with r2 values >0.98. The Diazyme Apo A-I Assay is not interfered by...

The Diazyme fecal Lactoferrin Assay is a particle-enhanced immunoturbidimetric assay. Lactoferrin in the sample binds to specific anti-Lactoferrin antibodies, which is coated on latex particles,...

The Diazyme High Sensitive C-Reactive Protein (hsCRP) Assay has a linear range of 0.20 - 20 mg/L that extends below the measurement range typical of most conventional CRP assay's. This lower range...

Diazyme's Cystatin C Assay is a convenient cost effective dual liquid stable latex enhanced immunoturbidimetric method. This critically important emerging marker aids in the early detection and...

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...

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...

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),...

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 %...

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...

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...

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...

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...

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...

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%...

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...

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...

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...

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...