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Cancer Antigen 15-3 CLIA Kit - India CDSCO Medical Device Registration

Cancer Antigen 15-3 CLIA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000078_eede9819e00f919b1f3bf6e068fb3b52_2b1e5485e167e300922d7320d30316da. This device is marketed under the brand name AFP+CEA+PSA. The license holder is Tosoh India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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 C
Cancer Antigen 15-3 CLIA Kit
UID: MFG/IVD/2021/000078_eede9819e00f919b1f3bf6e068fb3b52_2b1e5485e167e300922d7320d30316da

Brand Name

AFP+CEA+PSA

License Holder

Tosoh India Pvt. Ltd.

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

For the Quantitative Determination of Cancer Antigen 15-3 (AFP+CEA+PSA) Concentration in Human Serum by a Microplate Enzyme Immunoassay, Chemiluminescence

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