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ISO13485 POC Test Kit , Whole Blood D-Dimer Biochemistry Kits

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ISO13485 POC Test Kit , Whole Blood D-Dimer Biochemistry Kits

ISO13485 POC Test Kit , Whole Blood D-Dimer Biochemistry Kits
ISO13485 POC Test Kit , Whole Blood D-Dimer Biochemistry Kits ISO13485 POC Test Kit , Whole Blood D-Dimer Biochemistry Kits ISO13485 POC Test Kit , Whole Blood D-Dimer Biochemistry Kits ISO13485 POC Test Kit , Whole Blood D-Dimer Biochemistry Kits

Large Image :  ISO13485 POC Test Kit , Whole Blood D-Dimer Biochemistry Kits

Product Details:
Place of Origin: China
Brand Name: Lumigenex
Certification: ISO13485, cFDA
Model Number: High sensitivity 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

ISO13485 POC Test Kit , Whole Blood D-Dimer Biochemistry Kits

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


whole blood d dimer biochemistry kits


ISO13485 poc test kit

High sensitivity cFDA approved D-Dimer Quantitative Detection Kit (TRFIA)


1. Product Description


D-Dimer test kit is a time-resolved fluorescence immunochromatography technology used to quantitatively detection the concentration of D-Dimer in blood specimens. After adding blood specimen in reagent card, mat specimen of D-Dimer and markers of fluorescent microsphere decoupling D-Dimer monoclonal antibody to form complexes, and through the capillary chromatography to nitrocellulose membrane containing D-Dimer with another specific antibody detection, and captured, form double antibody sandwich composites. So more D-Dimer in the specimen, more compound accumulates on the test strip. The excess unreacted fluorescent microspheres were then computed to the control line. The fluorescence intensity on the detector line after the reagent strip is excited reflects the D-Dimer content captured in the specimen. The concentration of D-Dimer in the specimen was quantitatively reflected by the detection of time-resolved fluorescence immunoanalyzer LTRIC-600/LTRIC-300/LTRIC-1000.

Intended Use: 

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 High sensitivity cFDA approved D-Dimer Quantitative Detection Kit (TRFIA)
Specification 20 tests/box
Sample Whole blood, Plasma, Serum
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. High sensitivity 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. More Pictures

ISO13485 POC Test Kit , Whole Blood D-Dimer Biochemistry Kits 0

Contact Details
Lumigenex (Suzhou) Co. Ltd

Contact Person: Bonnie

Tel: 86-13814877381

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