TRFIA Medical Diagnostic D-Dimer Test Kit CFDA Certification

Medical Diagnostic cFDA approved D-Dimer Quantitative Detection Kit (TRFIA)

1. Product Description

Principle:

Intended Use: 

Medical Diagnostic cFDA approved D-Dimer test kit is suitable for use in vitro quantitative determination of D-Dimer in human whole blood/ plasma. D-Dimer is a specific marker of fibrinolysis, which can be used not only for the diagnosis of thrombotic diseases, but also for the monitoring and observation of therapeutic dose of thrombolytic drugs. At present, D-Dimer is mainly used for auxiliary diagnosis of the following diseases: diagnosis of disseminated intravascular coagulation (DIC), deep venous thrombosis (DVT), pulmonary embolism, myocardial infarction, cerebral infarction, etc. The detection platform of this project mainly includes immunoturbidimetric technology, immunofluorescence technology, colloidal gold technology, time-resolved fluorescence technology and so on.

2. Specification

3. Medical Diagnostic cFDA approved D-Dimer Quantitative Detection Kit (TRFIA) Main component

• 1 IC card
• 1 Instruction for use
• 20 or 50 Sample Buffer The test kit is individually sealed with a desiccant in an aluminum pouch. Reagent card consists of plastic stuck with strip, strip by sample mat, markers mat (on the main material for glass fiber, spray has the nanometer microspheres in mice against people of D-Dimer single fluorescent probe (solid content is 0.5%, microspheres 1:40 dilution)), detect membrane (main material for nitrocellulose membrane, spray has the person of D-Dimer in rat monoclonal antibody (1.5 mg/mL) and sheep immunoglobulin G (IgG) of the rat polyclonal antibody (1.0 mg/mL)), absorbing mat and polystyrene (PVC) plastic panels. Specimen test fluid 450 ul/ person, mainly composed of phosphate (PBS) buffer, containing 0.5% bovine serum albumin (BSA) and 0.05% preservative Proclin-300 (the main active ingredients are 2-methyl-4-isothiazoline-3-one and 5-chloro-2-methyl-4-isothiazoline-3-one).
• ※Do not exchange different batch numbers

4. Storage conditions and expiry date?

• The validity of test kit sealed in aluminum foil pouch is 18 months under condition of 2-8℃.
• The sealed test kit is stable for up to 30 days under room temperature (2-30℃) within validity period.
• Temperature change (< 37℃) during shipment has no effect on quality of the test kit.
• The unsealed kit is stable within 1 hour under ambient condition.

5. Applied Instrument