Tn-I Plus - India CDSCO Medical Device Registration

Tn-I Plus is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000198_092542a612bad7cd6cf0eb0cc628f899_373a0cc1385937d49f8de2449fbad4b3. This device is marketed under the brand name iChroma Tn-1 Neo. The license holder is CPC DIAGNOSTICS 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

Tn-I Plus

UID: IMP/IVD/2022/000198_092542a612bad7cd6cf0eb0cc628f899_373a0cc1385937d49f8de2449fbad4b3

Brand Name

iChroma Tn-1 Neo

License Holder

CPC DIAGNOSTICS PVT.LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

EZ POC Tn-I Plus is a fluorescence immunoassay (iChroma Tn-1 Neo) for the quantitative determination of cardiac troponin-I (iChroma Tn-1 Neo) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardial infarction (iChroma Tn-1 Neo)