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C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology

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C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology

C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology

Certification
China Lumigenex (Suzhou) Co. Ltd certification
China Lumigenex (Suzhou) Co. Ltd certification
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C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology

C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology
C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology

Large Image :  C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology

Product Details:
Place of Origin: China
Brand Name: Lumigenex
Certification: ISO13485, cFDA
Model Number: T2006-020, T2006-050
Payment & Shipping Terms:
Minimum Order Quantity: 1250 tests
Price: USD1.0/ Test
Packaging Details: 20 tests/box, 50 tests/box
Delivery Time: 2-10 days
Payment Terms: T/T, Western Union, Alipay
Supply Ability: 100,000 tests/day
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C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology

Description
Product Name: C Reactive Protein (CRP) Test Kit (TRFIA) Usage: Vitro Diagnostic Reagent
Type: Immunoassay System Application: Hospital Clinic Laboratory
Specimen: Whole Blood, Plasma, Serum Storing Temperature: 2℃-8℃
Shelf Life: 18 Months Place Of Origin: Jiangsu,China
Compatible Equipment: Lumigenex TRFIA Analyzer LTRIC-600, LTRIC-1000
High Light:

poc rapid strep test

,

poc kits

High sensitivity cFDA approved CRP Quantitative Detection Kit (TRFIA)

 

1. Product Description

 

Intended Use: 
The C-reactive protein test kit is suitable for quantitative determination of CRP in human whole blood/ serum/ plasma in vitro. The concentration of C-reactive proteins can be used as an auxiliary diagnostic tool to assess cardiovascular disease and inflammatory response. At present, the application of C reactive protein mainly includes the following aspects: adult postoperative stage, pulmonary infection, pediatric fever, myocardial infarction, gouty arthritis, osteoarthritis, gastrointestinal diseases, intestinal inflammatory diseases, Pediatric infectious diseases, etc.

 

C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology 0C Reactive Protein CRP Point Of Care Testing Kits CFDA Certification ImmunoassayTechnology 1

2. Specification

 

Product Name
C-Reactive Protein (CRP) Test Kit (TRFIA)
Method
Time Resolved Fluorescence Immunochromatographic Assay (TRFIA)
Certificates
ISO13495, CE
Usage
Vitro Diagnostic Reagent
Function
Inflammation Marker
Specimen
Whole Blood/ Serum/ Plasma
Test Kit Components
20 / 50 Test cards
20 / 50 Sample buffer
1 IC card
1 Instruction manual
Test Card Components
The test card is composed of a plastic cartridge and a test strip.
The strip consists of sample pad, a marker pad (Coated with a mouse anti-human CK-MB monoclonal antibody nano-microsphere fluorescent probe (0.5%), Detection membrane (coated with mouse anti human CK-MB monoclonal antibodies (1.5 mg/mL) and gout against mouse IgG polyclonal antibody (1.0 mg/mL)), absorbent paper and polystyrene (PVC) plywood.
Sample buffer, 1mL/test, mainly composed of phosphate (PBS) buffer, containing 0.5% calf serum albumin (BSA) and 0.05% preservative proclin-300 (main active ingredient Are 2-methyl-4-isothiazolin-3-one and 5-chloro-2-methyl-4-isothiazolin-3-one).
Storage & Shelf Life
Unopened test kit is stable for 18 months under 2-8℃, and up to 30 days under 2-30℃.
Temperature change (< 37℃) during shipment has no effect on quality of the test kit.
Unsealed test kit is stable within 1 hour
Compatible Equipment
Lumigenex Time-resolved Fluorescence Immunoanalyzer LTRIC-600, LTRIC-1000

 

 

Performance

Accuracy
Deviation from the quality control target value should be within ±15%.
Minimum detection limit
no higher than 0.1ug/mL.
Linearity
(0.2-50) ug/mL, the kit correlation coefficient R≥0.99
Repeatability
Coefficient of variation (CV) ≤15%.
Inter-batch difference
Inter-batch variation coefficient (CV) ≤15%.

 

4. Storage conditions and expiry date?

  • The unopened kit was stored in 2℃~8℃ for 18 months. The reagent card sealed in the aluminum foil bag package can be stored at temperature (2℃~30℃) for 30 days if it does not exceed expiry printed on the aluminum foil bag package. The temperature change during transportation (<37℃) has no effect on product quality. The reagent strip after the aluminum foil bag is unsealed can be stabilized for 1 hour at room temperature.
  • ※Do not exchange different batch numbers.

 

 

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Tag:

CFDA Approved Quantitative Rapid Test Kit,

CFDA Approved Quantitative Detection Kit,

SAA POC Test Kit Immunoassay

Contact Details
Lumigenex (Suzhou) Co. Ltd

Contact Person: Bonnie

Tel: 86-13814877381

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