Syphilis Ab Test - India CDSCO Medical Device Registration

Syphilis Ab Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000055_21055230a67b7d3a1ff4f19088507a4e_ced15b13610f0c7cc92be70df40a277f. This device is marketed under the brand name RAPHA SERO. The license holder is M/s Rapha Diagnostics PVt. Ltd.,, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

Syphilis Ab Test

UID: MFG/IVD/2021/000055_21055230a67b7d3a1ff4f19088507a4e_ced15b13610f0c7cc92be70df40a277f

Brand Name

RAPHA SERO

License Holder

M/s Rapha Diagnostics PVt. Ltd.,

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

Syphilis Ab Test is a rapid, serological, immunochromatographic assay for the qualitative detection of Syphilis antibodies (RAPHA SERO) to Treponema Pallidum (RAPHA SERO) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with TP. Any reactive specimen with the Syphilis Ab Rapid Test Cassette must be confirmed with alternative testing method(RAPHA SERO) and clinical findings

Class C

Syphilis Ab Test

Brand: Sensit

Ubio Biotechnology Systems Private Limited

Class B

Brand: SECURE

Class B