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Diagnostic Kit for C-reactive Protein (hsCRP&CRP) (Time-resolved Fluorescence Immunochromatographic assay)

Devices (same UDI-DI)
1
Certificates
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Countries
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Notified Bodies
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Basic Information

Primary DI
06974521000549
Basic UDI-DI Code
B-06974521000549
Reference
SUPF008025
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

This test is suitable for in vitro quantitative detection of the concentration of C-reactive protein in human serum, plasma and whole blood. This product is provided for testing by medical and health institutions, and is used for auxiliary diagnosis of patients' inflammation and other related diseases. C-reactive protein (CRP) is an acute phase reaction protein (APRP) synthesized by hepatocytes and can react with C-polysaccharide of Streptococcus pneumonia, molecular weight is 100,000-144,000. It is composed of five identical subunits aggregated by non-covalent bonds to form a ring-shaped symmetric pentamer. It exists in blood, cerebrospinal fluid, arthrosynovitis, liquor amnii, pleural effusion and blister fluid, and is part of non-specific immune mechanism. The main biological function of CRP is to activate complement and mononuclear phagocytic system by binding with ligands (phosphorylcholine of apoptotic and necrotic cells, or invasive bacteria, fungi, parasites, etc.) to clear pathogens or pathological cells with ligands. When infections, tissue damage and inflammatory diseases occur, CRP rises rapidly, up to a thousand times, and its content drops sharply after the disease is cured. Therefore, CRP detection can provide valuable information for the diagnosis, treatment and monitoring of inflammation and related diseases. CRP at low levels is closely related to the occurrence, severity and prognosis of cardiovascular and cerebrovascular diseases such as atherosclerosis and acute cerebral infarction. Therefore, hypersensitive CRP (hsCRP) can be used as an assistant means of cardiovascular disease risk identification.

CND Nomenclature Codes

Code Description
W01021109 C-REACTIVE PROTEIN

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