Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay )

Getein Biotech, Inc. · 🇨🇳 China
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
06954414702026
Basic UDI-DI Code
B-06954414702026
Reference
/
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Getein Biotech, Inc.

Additional Description

hs-CRP+CRP Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of C-reactive protein (CRP) in serum, plasma whole blood, or fingertip blood. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury and inflammatory disorders. Measurement of high sensitivity CRP (hs-CRP), when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes (ACS), may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or ACS. For professional and laboratory use only.

CND Nomenclature Codes

Code Description
W01021308 HIGH-SENSITIVITY C-.REACTIVE PROTEIN

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