IVD In Vitro Diagnostic D-Dimer POCT Test Kit With Plasma 25pcs/Kit

25 Tests/ Kit In Vitro Diagnostic Poct D-Dimer Test Kit With Plasma

【Intended use】

In vitro quantitative determination of D-Dimer in human plasma and human whole blood samples.

D-Dimer is a characteristic product in the degradation of cross-linked fibrin, which can be used in the auxiliary diagnosis of disseminated intravascular coagulation and monitoring of thrombolytic therapy.

The common detection methods include latex enhanced immunoturbidimetric assay, immunoturbidimetric assay and colloidal gold method.

【Storage conditions and validity period】

The test card and buffer can be stored at 2℃～30℃ for 15 months, and the buffer solution can be stored at 2℃～30℃ for 2h after opening the bottle . The aluminum foil bag of the test card should be used within 2 hours after it is opened. Transportation and storage should be carried out at 2℃～30℃.

【Product Performance Index】

1. The linear range: 0.10 mg / L ~ 10.00 mg / L. the D-Dimer samples with concentrations of 0.20 mg / L, 0.50 mg / L, 2.00 mg / L, 5.00 mg / L and 10.00 mg / L were detected with the same batch of D-Dimer reagent, and the correlation coefficient r was ≥ 0.9900.

2. Measurement precision

2.1 repeatability: within run CV ≤ 15.0%.

2.2 difference between batches: difference between batches ≤ 15.0%.

3. Accuracy: the relative deviation is within ± 15.0%.

4. Blank limit: no more than 0.10mg/l.

【Specification】

【Certificate】

【Exhibition】