Syphilis Ab Rapid Test - India CDSCO Medical Device Registration

Syphilis Ab Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_599b32e873699a913259abc373b9d3fd_f9d5240e55f9a98312a0af4e4ade9cba. 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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CDSCO Registered

Class Class D

Syphilis Ab Rapid Test

UID: MFG/IVD/2020/000046_599b32e873699a913259abc373b9d3fd_f9d5240e55f9a98312a0af4e4ade9cba

Brand Name

TRUSTline

License Holder

Athenese-Dx Private Limited

Device Class

Class D

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The TRUSTline Syphilis Ab Rapid Test 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