Diazyme Laboratories D-Dimer Control

Diazyme D-Dimer Control set is for the testing of D-Dimer in human plasma.

Manufacturer:  Diazyme Laboratories DZ179ACON

Catalog No. 23-700-619

Description

• 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

• Format: 2 x 1 mL Vial
• Type: Diagnostic
• CE Marker: Yes
• Description: D-Dimer Assay Control Set
• Stability: Unopened vials: stability is up to the expiration date on label when stored at 2 to 8°C After reconstitution: stability is 14 days when stored at 2 to 8°C

• Storage Requirements: 2°C to 8°C. DO NOT FREEZE. Note: Store CONTROL tightly capped when not in use.
• Certifications/Compliance: 510(k) Cleared, EU: CE IVD
• Concentration: Lab dependent
• Includes: The Diazyme D-Dimer Control Set is a two-level set that is supplied in lyophilized form (2 x 1 mL). The controls are manufactured from human serum. The concentrations of the controls are lot specific and D-Dimer concentrations are expressed in μg/mL FEU.