Free Prostate Specific Antigen CLIA - India CDSCO Medical Device Registration

Free Prostate Specific Antigen CLIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000083_ade1809912ff1dd14e1cd98a27f2129d_5d962c03b383d2044e3c85b38abd3ee5. 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.

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CDSCO Registered

Class Class C

Free Prostate Specific Antigen CLIA

UID: IMP/IVD/2021/000083_ade1809912ff1dd14e1cd98a27f2129d_5d962c03b383d2044e3c85b38abd3ee5

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 Free Prostate Specific Antigen (CA 19-9) concentration in Human serum by a Microplate chemiluminescence immunoassay