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/2021/000083_de3405844b31a595ff6d6717187e1a8e_8dc419a70ae6b38a88da2a948d3d8cf6. This device is marketed under the brand name CA 19-9. The license holder is HAPTEN BIOSYSTEMS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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.

Free Database

CDSCO Registered

Class Class C

Prostate Specific Antigen CLIA

UID: IMP/IVD/2021/000083_de3405844b31a595ff6d6717187e1a8e_8dc419a70ae6b38a88da2a948d3d8cf6

Brand Name

CA 19-9

License Holder

HAPTEN BIOSYSTEMS PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

For the quantitative determination of Total Prostate Specific Antigen (CA 19-9) concentration in Human serum by a Microplate chemiluminescence immunoassay