USA: 510(k)

Quantitative in vitro assay for oxalate in human 24‑hour urine to aid in diagnosis and management of kidney stone–related conditions and other metabolic disorders. Product Catalog Number

Diazyme Colorimetric Lithium Assay kit is for quantitative in vitro determination of lithium in human serum or EDTA plasma. Product Catalog Number Format

Diazyme's Pancreatic Elastase Assay is a particle-enhanced immunoturbidimetric assay. Pancreatic Elastase in the sample binds to specific anti-Pancreatic Elastase antibodies, which is coated on...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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 Catal

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...

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...

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...