Cardiac Triple - India CDSCO Medical Device Registration

Cardiac Triple is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000198_e75de94916bc5c20c62ef7bbf514d695_003cfbd9d636d4913aa37e9e65634f42. 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

Cardiac Triple

UID: IMP/IVD/2022/000198_e75de94916bc5c20c62ef7bbf514d695_003cfbd9d636d4913aa37e9e65634f42

Brand Name

iChroma Tn-1 Neo

License Holder

CPC DIAGNOSTICS PVT.LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

EZ POC Cardiac Triple is a fluorescence immunoassay (iChroma Tn-1 Neo) for the quantitative determination of Cardiac troponin-I (iChroma Tn-1 Neo), Creatine kinase (iChroma Tn-1 Neo) and Myoglobin in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardial infarction (iChroma Tn-1 Neo) and acute coronary syndrome (iChroma Tn-1 Neo).

Class C

Tn-I Plus

Brand: iChroma Tn-1 Neo

CPC DIAGNOSTICS PVT.LTD

Class C

Class A