LIAISON® Control fPSA - India CDSCO Medical Device Registration

LIAISON® Control fPSA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000089_b06c2998b6ed8f4edbb924abcca89811_bad74a3780dbc45c54dc063f1cc5732a. 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® Control fPSA

UID: IMP/IVD/2019/000089_b06c2998b6ed8f4edbb924abcca89811_bad74a3780dbc45c54dc063f1cc5732a

Brand Name

LIAISON® Tg II Gen Confirmatory

License Holder

Diasorin Healthcare India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The LIAISON® fPSA controls (LIAISON® Tg II Gen Confirmatory) are to be used in LIAISON® fPSA chemiluminescent immunoassays (LIAISON® Tg II Gen Confirmatory) as a means of checking reliability of assay runs. The performance characteristics of LIAISON® Control fPSA have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL

Class C

Brand: LIAISON® EASY System Liquid

Class B