CK-MB FIA Test - India CDSCO Medical Device Registration

CK-MB FIA Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000062_cbdfd7f1a1e17f8dc58816334f797884_ccaed508d12e4fb3e686f17f84c8aefb. This device is marketed under the brand name hCG. The license holder is Mylab Discovery Solutions Pvt. Ltd. Lonavla, and it is classified as Device Class Class B. The approving authority is Pune Division.

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CDSCO Registered

Class Class B

CK-MB FIA Test

UID: MFG/IVD/2021/000062_cbdfd7f1a1e17f8dc58816334f797884_ccaed508d12e4fb3e686f17f84c8aefb

Brand Name

hCG

License Holder

Mylab Discovery Solutions Pvt. Ltd. Lonavla

Device Class

Class B

Approving Authority

Pune Division

Product Information

CK-MB FIA Test is a fluorescence immunoassay for the quantitative determination of total Creatine Kinase Isoenzyme-MB (hCG) levels in the human specimen using FIA Analyzers. This test is an in vitro diagnostic use and intended for use as an aid in the screening and monitoring of myocardiac infarction (hCG). The test is intended for professional testing. More specific alternative diagnosis methods should be performed to obtain the confirmation of total CK-MB

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CK-MB FIA Test - India CDSCO Medical Device Registration

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Approving Authority

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