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Diagnostic Kit for Cardiac Troponin I - India CDSCO Medical Device Registration

Diagnostic Kit for Cardiac Troponin I is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000169_9490159ad89edf8d87adcf97e3a657be_ec13c0a4334a11daad9f7614b2c13897. This device is marketed under the brand name cTnI. The license holder is Arkray Healthcare Pvt., Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Diagnostic Kit for Cardiac Troponin I
UID: IMP/IVD/2023/000169_9490159ad89edf8d87adcf97e3a657be_ec13c0a4334a11daad9f7614b2c13897

Brand Name

cTnI

Device Class

Class C

Approving Authority

CDSCO

Product Information

This kit uses double antibody sandwich method principle and fluorescence immunochromatography analysis technology to quantitatively detect the concentration of cTnI in human serum, plasma, and whole blood samples

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