CK-MB Neo - India CDSCO Medical Device Registration

CK-MB Neo is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000198_2d3b93bb55a98df99c3aed75ff6a50ed_3b0d754b7b1d10af83eb77c9cb653197. 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

CK-MB Neo

UID: IMP/IVD/2022/000198_2d3b93bb55a98df99c3aed75ff6a50ed_3b0d754b7b1d10af83eb77c9cb653197

Brand Name

iChroma Tn-1 Neo

License Holder

CPC DIAGNOSTICS PVT.LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

ichromaTM CK-MB Neo is a fluorescence Immunoassay (iChroma Tn-1 Neo) for the quantitative determination of Creatine Kinase Isoenzyme-MB (iChroma Tn-1 Neo) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardiac 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