Prostate Specific Antigen CLIA - India CDSCO Medical Device Registration

Prostate Specific Antigen CLIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000391_de3405844b31a595ff6d6717187e1a8e_aba90017d13f6ff0f17cade167e3c1b3. This device is marketed under the brand name f-bHCG. The license holder is Tosoh India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Prostate Specific Antigen CLIA

UID: IMP/IVD/2019/000391_de3405844b31a595ff6d6717187e1a8e_aba90017d13f6ff0f17cade167e3c1b3

Brand Name

f-bHCG

License Holder

Tosoh India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

For the quantitative determination of Total Prostate Specific Antigen (f-bHCG) concentration in Human serum by a Microplate chemiluminescence immunoassay