Syphilis ELISA Test - India CDSCO Medical Device Registration

Syphilis ELISA Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000065_80df5c5cd6eeccea914234c2ba63ad2e_24c64f2baca7e05988edf095e62d9df0. This device is marketed under the brand name Q-LISA. The license holder is Q-Line Biotech Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class C

Syphilis ELISA Test

UID: MFG/IVD/2020/000065_80df5c5cd6eeccea914234c2ba63ad2e_24c64f2baca7e05988edf095e62d9df0

Brand Name

Q-LISA

License Holder

Q-Line Biotech Private Limited

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The Q-LISA Syphilis Ab ELISA Kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of antibodies (Q-LISA) against Treponema pallidum in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with Tp. Any reactive specimen with the Aria Syphilis Ab ELISA Kit must be confirmed with alternative testing method(Q-LISA) and clinical findings