Getein Biotech, Inc.

The One Step Test for D-Dimer (colloidal gold) is intended for use together with the FIA8000 Quantitative Immunoassay Analyzer (FIA8000). The product employs colloidal gold immunechromatogrphy to determine D-Dimer in human plasma, or whole blood specimens. Two monoclonal antibodies are employed to identify D-Dimer specifically, resulting in a purplish red streak appears on the test line. The color intensity of the test line increases in proportion to the concentrations of D-Dimer.

Then insert test card into the FIA8000 Quantitative Immunoassay Analyzer, the concentration of D-Dimer is measured quantitatively and displayed on the screen. The result can be transmitted to the lab or hospital information system.

Products Code: CG 1006

Detection Method: colloidal gold, a quantitative test for use with the FIA8000 Quantitative Immunoassay Analyzer. 

Detection Range: 0.1-10.0 mg/L

Cut-off Value: 0.5 mg/L

Sample Type: plasma or whole blood in Sodium Citrate.

Reaction Time: yields results in about 7 minutes.

Storage Temperature: 4-30°C

1. As an aid in the exclusion of venous thromboembolism (VTE);

2. As an aid in the exculsion of pulmonary embolism(PE);

3. As an aid in the diagnosis of disseminated intravascular coagulation (DIC);

4. As an aid in the diagnosis and prognosis of cerebral infarction;

5. As an aid in the evaluation of coagulation status of pregnancy-induced hypertension;

6. As an aid in the diagnosis and prognosis of patients with surgery; monitor the thrombolytic therapy.