Syphilis Ab Test
- UID
- MFG/IVD/2021/000055_21055230a67b7d3a1ff4f19088507a4e_ced15b13610f0c7cc92be70df40a277f
- Device class
- Class C
- Brand name
- RAPHA SERO
- License holder
- M/s Rapha Diagnostics PVt. Ltd.,
- 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
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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