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Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification

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China Lumigenex (Suzhou) Co. Ltd certification
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Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification

Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification
Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification

Large Image :  Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification

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

Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification

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:

CRP Test Kit ISO13485

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CRP IVD Test Kit CE Certification

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Fluorescence Immunoassay CRP Test Kit

C Reactive Protein Detection Kit CRP IVD Test Kit CE Certification Fluorescence ImmunoassayTechnology

High sensitivity cFDA approved CRP Quantitative Detection Kit (TRFIA)

 

 

Intended Use
The C-reactive protein test kit may be used to quantify CRP in human whole blood, serum, or plasma in vitro. C-reactive protein concentrations may be used as an adjunct diagnostic tool to evaluate cardiovascular disease and inflammatory response. C reactive protein is now used to treat the following conditions: adult postoperative stage, lung infection, pediatric fever, myocardial infarction, gouty arthritis, osteoarthritis, gastrointestinal disorders, intestinal inflammatory diseases, pediatric infectious diseases, and so on.

 

Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification 0Fluorescence Immunoassay C Reactive Protein Detection Kit CE Certification 1

 

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 kits are stable for 18 months at 2-8°C and up to 30 days at 2-30°C.
Temperature changes (37°C) during transportation have no influence on the test kit's quality.
The 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%.

 

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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Contact Details
Lumigenex (Suzhou) Co. Ltd

Contact Person: Bonnie

Tel: 86-13814877381

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