Diazyme Laboratories D-Dimer Assay

Description

Diazyme D-Dimer Assay is for the quantitative determination of fibrinogen/fibrin degradation products (D-Dimer) in human plasma.

• 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 of 0.15 - 8.0 μg/mL FEU with a correlation coefficient value of 0.939, slope of 0.979 and y intercept of -0.106
• The following substances do not interfere with this assay at the levels tested less than 10% bias: Hemoglobin up to 500 mg/dL, Bilirubin 40 mg/dL, Bilirubin conjugated 40mg/dL, Triglycerides 1000 mg/dL, Ascorbic Acid 176 mg/dL, Rheumatoid Factor 100 IU/mL, Heparin 1.5 IU/mL and HAMA 490 ng/mL
• Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis
• For in vitro diagnostic use only

Specifications

• Certifications/Compliance: 510(k) Cleared, EU: CE IVD
• Content And Storage: D-Dimer assay reagents, calibrators, and controls should be stored at 2 to 8°C. DO NOT FREEZE
• Description: D-Dimer Assay Kit
• CE Marker: Yes
• Concentration: Lab dependent
• Type: Diagnostic
• Includes: R1 and R2
• Linearity: Eleven levels of the D-Dimer linearity set were prepared by diluting a specimen containing 8.0 μg/mL FEU with saline according to Clinical and Laboratory Standards Institute EP6-A and tested on Modular P. Diazyme D-Dimer assay is linear from 0.15 to 8.0 μg/mL FEU.
• Packaging Type: Universal
• Stability: The reagents, calibrators, and controls are sta-ble when stored as instructed until the expiration date on the label. Open reagent bottles are stable for 4 weeks if stored on board the refrigerated compartment of the Roche Modular P analyzer.
• Form: Liquid