Troponin T - India CDSCO Medical Device Registration

Troponin T is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000198_550aa0aa2a2644f29ac813df1dd38b60_34ed995d23d7d3bdab6c97f19da1cdfa. 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

Troponin T

UID: IMP/IVD/2022/000198_550aa0aa2a2644f29ac813df1dd38b60_34ed995d23d7d3bdab6c97f19da1cdfa

Brand Name

iChroma Tn-1 Neo

License Holder

CPC DIAGNOSTICS PVT.LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

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