Cancer Antigen CLIA - India CDSCO Medical Device Registration

Cancer Antigen CLIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000083_d8ef9466d9d06bd8c4c1ef548c799740_f1b225e2fbc2eedb6bfa1ee913999093. 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

Cancer Antigen CLIA

UID: IMP/IVD/2021/000083_d8ef9466d9d06bd8c4c1ef548c799740_f1b225e2fbc2eedb6bfa1ee913999093

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 Cancer Antigen 15-3 (CA 19-9) concentration in Human serum by a Microplate chemiluminescence assay

DJ Fang

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