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CK-MB Test Kit - India CDSCO Medical Device Registration

CK-MB Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000082_ee5de77f691245d1e917a85990e704cf_6271544e872ff56f02167ae0e1c4bc3c. This device is marketed under the brand name BIOGENIX. The license holder is Biogenix Inc. Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Uttar Pradesh.

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 Test Kit
UID: MFG/IVD/2020/000082_ee5de77f691245d1e917a85990e704cf_6271544e872ff56f02167ae0e1c4bc3c

Brand Name

BIOGENIX

Device Class

Class B

Approving Authority

Uttar Pradesh

Product Information

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

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