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Diagnostic Kit for Procalcitonin (PCT) (Time-resolved Fluorescence Immunochromatographic Assay)

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

Primary DI
06974521000709
Basic UDI-DI Code
B-06974521000709
Reference
SUPF007025
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

This kit is suitable for in vitro quantitative detection of the concentration of Procalcitonin (PCT) in human serum, plasma and whole blood. This product is used for testing in medical and health institutions for the auxiliary diagnosis of systemic bacterial infection and sepsis in clinical practice. PCT is the precursor of calcitonin without hormonal activity. It is a glycoprotein composed of 116 amino acids, including calcitonin and N-terminal residues. Under physiological conditions, PCT is mainly synthesized and secreted by thyroid C cells. During bacterial infection, macrophages and monocytes in the liver, lymphocytes and endocrine cells in lung and intestinal tissues synthesize and secrete a large amount of PCT under the action of endotoxins, tumor necrosis factor-α and interleukin-6, leading to a significant increase in serum PCT level. In clinical diagnosis, the higher the PCT level, the more serious the infection and the worse the prognosis. The PCT concentration in patients with sepsis increased earlier, which is convenient for early diagnosis and monitoring. In addition, PCT can specifically distinguish the important markers of bacterial infection and other inflammatory reactions. Virus infection, allergic reaction, autoimmune diseases and transplant rejection do not cause a significant increase in PCT, while bacterial infection can lead to an increase in PCT concentration.

CND Nomenclature Codes

Code Description
W0102069013 PROCALCITONIN

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