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Diagnostic Kit for Serum Amyloid A(SAA) (Time-resolved Fluorescence Immunochromatographic Assay)

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
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Basic Information

Primary DI
06974521000730
Basic UDI-DI Code
B-06974521000730
Reference
SUPF039025
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 human serum amyloid A (SAA) in human serum, plasma, whole blood. The product is used for auxiliary diagnosis of patients' inflammation and other related diseases. Serum amyloid A (SAA) is a polymorphic protein family encoded by polygenes, and the precursor material of tissue amyloid A is a type of acute amyloid protein. In the acute phase of inflammation or infection, it increases rapidly within 4~6h and decreases rapidly in the recovery period of the disease. Currently, elevated serum SAA is detected in bacterial and viral infections, atherosclerosis, coronary heart disease, acute graft rejection, tumor and other diseases. The sensitivity of SAA is higher than that of CRP for some diseases, such as virus infection, graft rejection, coronary heart disease, etc., which can provide better reference value for clinical practice. As a new indicator, SAA is attracting more and more attention.

CND Nomenclature Codes

Code Description
W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER

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