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Creatine kinase-MB - India CDSCO Medical Device Registration

Creatine kinase-MB is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000017_a85501e62508d30eb524002feb1f982a_8269bc8e6cab8d662cff2795cdd2fdaf. This device is marketed under the brand name ISEPAK / TURBOLYTE ISEPAK / ISEPAK-ER. The license holder is AGD BIOMEDICALS P LTD, and it is classified as Device Class Class B. The approving authority is Kokan Division.

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CDSCO Registered
Class Class B
Creatine kinase-MB
UID: MFG/IVD/2021/000017_a85501e62508d30eb524002feb1f982a_8269bc8e6cab8d662cff2795cdd2fdaf

Brand Name

ISEPAK / TURBOLYTE ISEPAK / ISEPAK-ER

License Holder

AGD BIOMEDICALS P LTD

Device Class

Class B

Approving Authority

Kokan Division

Product Information

It is intended for in vitro quantitative determination of CK MB levels in Serum and Plasma

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