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/2022/000457_5653735ba440bf5f2b40b2f7738e89dc_46e7abba8c899c279498a8725d8d1f2b. This device is marketed under the brand name cTnI. The license holder is M/S CLEAR IMAGING MEDICAL SYSTEM 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/2022/000457_5653735ba440bf5f2b40b2f7738e89dc_46e7abba8c899c279498a8725d8d1f2b

Brand Name

cTnI

License Holder

M/S CLEAR IMAGING MEDICAL SYSTEM PVT. LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

This kit is suitable for in vitro quantitative detection of the concentration of Troponin I (cTnI) in human serum, plasma and whole blood. This product is used for testing in medical and health institutions for the auxiliary diagnosis of myocardial injury caused by acute myocardial infarction and other diseases