Syphilis Ab Rapid Test - Dip Strip
- UID
- MFG/IVD/2020/000046_ec54be2cb99119d6cbd4fb06cc11a9f2_b1b6e290de1f54d1e294a49ce65b8810
- Device class
- Class D
- Brand name
- TRUSTline
- License holder
- Athenese-Dx Private Limited
- Approving authority
- Central Drug Standard Control Organisation, South Zone
- Product information
- The TRUSTline Syphilis Ab Rapid Test - Dip Strip is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (TRUSTline) to Treponema pallidum (TRUSTline) in human serum or plasma. It is intended to be used by healthcare professionals as a screening test and as an aid in the diagnosis of infection with Tp. The test is not automated and does not require any additional instrument. Any reactive specimen with the TRUSTline Syphilis Ab Rapid Test must be confirmed with alternative testing method(TRUSTline) and clinical findings
Syphilis Ab Rapid Test - Dip Strip is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_ec54be2cb99119d6cbd4fb06cc11a9f2_b1b6e290de1f54d1e294a49ce65b8810. This device is marketed under the brand name TRUSTline. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class D. The approving authority is Central Drug Standard Control Organisation, South Zone.
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