One Step Test for D-Dimer 

(Colloidal Gold)

Intended Use

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 immunochromatography to determine D-Dimer in human plasma, or whole blood specimens. This test is used as an aid in the assessment and exclusion of suspected deep vein thrombosis (DVT) or pulmonary embolism (PE) in the Physical Department or emergency room (ER).

Contents

A box package contains 25 tests:

1) 25 Foil bags, which contains one test card and one desiccant

2) 25 Disposable pipets

3) 1 Manual

4) 1 SD card

5) 25 Sample diluents

Specifications

Applicable Device

Getein1100 Immunofluorescence Quantitative Analyzer

FIA8000 Quantitative Immunoassay Analyzer.

Clinical Application

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

2. As an aid in the exclusion 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.