LIAISON® PSA - India CDSCO Medical Device Registration

LIAISON® PSA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000089_fd678b26f00c43507dac1181dfa068d4_f03e00149ad60b7d1bfb8661e01686b6. This device is marketed under the brand name LIAISON® Tg II Gen Confirmatory. The license holder is Diasorin Healthcare 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

LIAISON® PSA

UID: IMP/IVD/2019/000089_fd678b26f00c43507dac1181dfa068d4_f03e00149ad60b7d1bfb8661e01686b6

Brand Name

LIAISON® Tg II Gen Confirmatory

License Holder

Diasorin Healthcare India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

In vitro assay for the quantitative determination of human prostate-specific antigen (LIAISON® Tg II Gen Confirmatory) in human serum and plasma (LIAISON® Tg II Gen Confirmatory) during the follow-up of patients with carcinoma of the prostate. The test has to be performed on the LIAISON® Analyzer family

Class C

Brand: LIAISON Light Check 12

Class A