CK-MB - India CDSCO Medical Device Registration

CK-MB is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000198_8a863ab9781ae23a57fffc35f97a621d_20fe786f5f12ceee04089d53ae10d579. This device is marketed under the brand name ichroma™ Myoglobin neo. The license holder is CPC DIAGNOSTICS PVT.LTD, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

CK-MB

UID: IMP/IVD/2022/000198_8a863ab9781ae23a57fffc35f97a621d_20fe786f5f12ceee04089d53ae10d579

Brand Name

ichroma™ Myoglobin neo

License Holder

CPC DIAGNOSTICS PVT.LTD

Device Class

Class B

Approving Authority

CDSCO

Product Information

EZ POC CK-MB is a fluorescence immunoassay (ichroma™ Myoglobin neo) for the quantitative determination of Creatine Kinase Isoenzyme-MB (ichroma™ Myoglobin neo) in human whole blood/serum/ plasma. It is useful as an aid in management and monitoring of acute myocardiac infarction (ichroma™ Myoglobin neo) and acute coronary syndrome (ichroma™ Myoglobin neo)