USA: 510(k)

The DZ-Lite OxPL Lipoprotein Assay is a magnetic particle based chemiluminescent immunoassay similar to the chemiluminescent ELISA assay as described by Tsimikas S. et al26-27 with modifications in Kiechl et al28 and Bertoia et al.4 In the assay .…

Diazyme OxLDL Assay is based on latex enhanced immunoturbidimetric method. OxLDL molecules in the sample bind to the specific anti-OxLDL antibodies that are coated on latex particles, and which causes agglutination. Product Catalog...

Diazyme's Fibrinogen Assay is a highly sensitive liquid stable immunoturbidimetric test kit, designed to work on most open clinical chemistry analyzers to provide rapid results with reduced reagent cost. The Fibrinogen Assay is linear up to 1032.8...…

Diazyme's Homocysteine (HCY) 2 Reagent Enzymatic Assay is a convenient dual vial liquid stable assay ideal for analyzers which require two-part reagent systems. The assay provides a fast, accurate cost-effective alternative to cumbersome and expensiv…

The Diazyme Enzymatic Homocysteine (Hcy) Assay reagent is a liquid stable system, which provides a fast, accurate cost effective alternative to cumbersome and expensive immunochemical methods. Accurate and reliable, the assay features excellent...

Diazyme's Procalcitonin (PCT) Assay is for the quantitative determination of PCT in Serum, EDTA or Lithium Heparin plasma samples. PCT should be measured according to specific application parameters for specific chemistry analyzers. Diazyme's PCT Ass…

The Diazyme Calprotectin Assay is a particle-enhanced immunoturbidimetric assay. Calprotectin in the sample binds to specific anti-calprotectin antibodies, which is coated on latex particles, and causes agglutination. Product Catalog Number Forma…

Diazyme's Retinol Binding Protein (RBP) is a dual liquid stable reagent system which provides reliable results. The method requires only 3 μL of sample, completed in less than 10 minutes, and has excellent correlation with existing commercial...

Diazyme's D-Dimer Assay is a highly sensitive liquid stable latex enhanced immunoturbidimetric test kit, designed to work on most open clinical chemistry analyzers to provide rapid results with reduced reagent cost. The D-Dimer Assay has a linearity …

Diazyme's Human Lambda Free Light Chain (FLC) assay has excellent across the Analytical Measuring Interval (AMI) in standard mode: 3.5 – 200 mg/L ; extended mode: 3.5 – 4000 mg/L. The method comparison gave a linear regression coefficient…

Diazyme's Human Kappa Free Light Chain (FLC) assay has excellent across the Analytical Measuring Interval (AMI) in standard mode: 3.5 – 200 mg/L ; extended mode: 3.5 – 4000 mg/L. The method comparison gave a linear regression coefficient …

Diazyme's Direct HbA1c (Enzymatic, On-Board Lysis) is a unique single channel assay ideal for labs requiring a high throughput HbA1c method with no off-line pretreatment steps. High throughput is obtained using a patented single channel method which.…

Diazyme's IFCC certified Direct Enzymatic HbA1c Assay has no interference from hemoglobin variants including HbC, HbS, HbE, and caramylated acetylated Hb or labile HbA1c. This unique freedom from interference combined with unparalleled precision (int…

The Diazyme β-Hydroxybutyrate (BHB) Assay is for the Quantitative Determination of β-Hydroxybutyrate in human serum or plasma. For in vitro diagnostic use only. Description Catalog Number Packaging β-Hydroxybutyrate (BHB) Assay…

1,5-AG reflects hyperglycemia above the renal threshold over the preceding 1-2 weeks which is complimentary to HbA1c and Glycated Serum Protein determinations. The test provides a useful, unique perspective of patient's recent hyperglycemic excursion…

Diazyme's Myoglobin Assay is based on latex enhanced immunoturbidimetric method. The assay is formulated in a convenient dual liquid stable format, and it is highly cost effective. Myoglobin is a cardiac biomarker that helps diagnose or rule out hear…

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 substances at the indicated concentrations:…

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 following substances at the indicated...

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 of measurement may include the evaluation of conditio…

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 diagnosis of renal disease. The assay is highly sensitiv…