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TRFIA Medical Diagnostic D-Dimer Test Kit CFDA Certification

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TRFIA Medical Diagnostic D-Dimer Test Kit CFDA Certification

TRFIA Medical Diagnostic D-Dimer Test Kit CFDA Certification
TRFIA Medical Diagnostic D-Dimer Test Kit CFDA Certification TRFIA Medical Diagnostic D-Dimer Test Kit CFDA Certification TRFIA Medical Diagnostic D-Dimer Test Kit CFDA Certification

Large Image :  TRFIA Medical Diagnostic D-Dimer Test Kit CFDA Certification

Product Details:
Place of Origin: China
Brand Name: Lumigenex
Certification: ISO13485, cFDA
Model Number: Medical Diagnostic cFDA approved D-Dimer Quantitative Detection Kit (TRFIA)
Payment & Shipping Terms:
Minimum Order Quantity: Negotiable
Price: Negotiable
Packaging Details: 20 tests/box
Delivery Time: depends on order quantity
Payment Terms: L/C, T/T, Western Union, MoneyGram
Supply Ability: 100,000 tests/day

TRFIA Medical Diagnostic D-Dimer Test Kit CFDA Certification

Description
Product Name: Medical Diagnostic CFDA Approved D-Dimer Quantitative Detection Kit (TRFIA) Specification: 20 Tests/box
Certificate: ISO13485, CFDA Specimen: Whole Blood, Plasma
Storing Temperature: 2℃-8℃ Shelf Life: 18 Months
Place Of Origin: Jiangsu,China Production Capacity: 100,000 Tests/day
Technology: TRFIA OEM: Available
High Light:

TRFIA d dimer test kit

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cFDA d dimer test kit

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cFDA medical diagnostic test kit

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

 

1. Product Description

Principle:

D-dimers are fission products of fibrin and play an important role in blood coagulation. Elevated D-dimer levels are found in patients with confirmed deep venous thrombosis (DVT), pulmonary embolism (PE), disseminated intravascular coagulation (DIC) and trauma. The levels rise during pregnancy and considerably high levels are associated with possible complications. D-dimer concentration by itself does not imply anything, which gives it a non-specific character. Nevertheless, if D-dimer concentration is not elevated, pulmonary embolism can be ruled out as a possible complication with high probability.

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

Product Name  Medical Diagnostic cFDA approved D-Dimer Quantitative Detection Kit (TRFIA)
Specification 20 tests/box
Sample Whole blood, Plasma
Storage Temperature 2℃-8℃
Certificate ISO13485/cFDA
Place of Origin Suzhou, Jiangsu, China
MOQ Negotiable, Accept small quantity
Lead Time Depends on the order, 1~15 working days
Tips Best to inquire for shipping details. We will contact you within 24 hours. Door to door service can be provided in some areas.

 

3. Medical Diagnostic cFDA approved D-Dimer Quantitative Detection Kit (TRFIAMain 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

TRFIA Medical Diagnostic D-Dimer Test Kit CFDA Certification 0

 

Contact Details
Lumigenex (Suzhou) Co. Ltd

Contact Person: Bonnie

Tel: 86-13814877381

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