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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/2021/000365_8a863ab9781ae23a57fffc35f97a621d_07d65532fafe9ee3aff40e7fdb96c080. This device is marketed under the brand name AFIAS Infliximab . The license holder is BODITECH MED INDIA PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
CK-MB
UID: IMP/IVD/2021/000365_8a863ab9781ae23a57fffc35f97a621d_07d65532fafe9ee3aff40e7fdb96c080

Brand Name

AFIAS Infliximab

Device Class

Class B

Approving Authority

CDSCO

Product Information

AFIAS CK-MB is a fluorescence Immunoassay (AFIAS Infliximab ) for the quantitative determination of Creatine Kinase Isoenzyme-MB (AFIAS Infliximab ) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardiac infarction (AFIAS Infliximab ) and acute coronary syndrome (AFIAS Infliximab )

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