D-Dimer Detection of Venous Thromboembolism for Emergency Medical Testing

• Type: IVD Reagent
• Test Item: D-Dimer Fast Test Kit
• Sample: Plasma or Whole Blood in Sodium
• Certificate: CE, Nmpa, ISO
• Test Time: 10 Min
• Storage Condition: 4-30 ºC
• Model NO.: D-Dimer Fast Test Kit
• Transport Package: Carton
• Specification: 25 tests/BOX
• Trademark: Getein
• Origin: China

Product Description

Product Description

 

D-Dimer
Fast Test Kit
(Immunofluorescence Assay)

 

Intended Use

D-Dimer Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of D-Dimer in plasma or whole blood. The test is used as an aid in the assessment and evaluation of patients suspected of deep-vein thrombosis or pulmonary embolism.

D-Dimer
D-Dimer is a marker of endogenous fibrinolysis and should therefore be detectable in patients with deep-vein thrombosis.
In recent years, an increasing number of studies have shown the D-Dimer assay has a high negative predictive value and
D-Dimer is a sensitive but nonspecific marker of deep-vein thrombosis. Negative D-Dimer can exclude deep-vein thrombosis and pulmonary embolism.




Specifications

Product Name	Sapmle	Test Time	Storage Condition	Shelf Life
D-Dimer Fast Test Kit (Immunofluorescence Assay)	Plasma, Whole Blood	10 min	4-30ºC (test cards)	24 months
Test Item	Kit Size	Method	Product Code	Certificate
D-Dimer	25 kits/box	Immunofluorescence Assay	IF 1006	CE, ISO 13485

Contents

A kit for Getein1100 contains:
Package specifications: 25 tests/box, 10 tests/box
1) D-Dimer test card in a sealed pouch with desiccant
2) Disposable pipet
3) Sample diluent
4) User manual: 1 piece/box
5) SD/RFID card: 1 piece/box

Applicable Device
 

Getein1100 Immunofluorescence Quantitative Analyzer

 

 

 

 

 

Operati

Storage and Stability

Store the test card at 4~30ºC with a valid period of 24 months. Use the test card for Getein1100 within 1 hour once the foil pouch is opened.
For test card of Getein1600: if the cartridge is opened, it could be stable within 24 hours once exposed to air. If the test cards can't be used up at a time, please put the cartridge back to the foil pouch and reseal along the entire edge of zip-seal. The remaining test cards should be used up within 7 days.
Store the sample diluent at 0~30ºC with a valid period of 24 months.
Store the sample diluent at 2~8ºC for better results.


Operation









Contact:

Getein Biotech, Inc. 
 

 

Add.: No.9 Bofu Road, Luhe District, Nanjing (211505) China.