Syphilis Ab ELISA Kit - India CDSCO Medical Device Registration
Syphilis Ab ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000034_f029dbb7ffab61c47e9b8d7f1e926ea0_6b81775a19b175d70a63f7be39a5d3bb. This device is marketed under the brand name TRUSTwell . 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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Brand Name
TRUSTwell
License Holder
Athenese-Dx Private LimitedDevice Class
Approving Authority
Central Drug Standard Control Organisation, South Zone
Product Information
The TRUSTwell Syphilis Ab kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of antibodies (TRUSTwell ) against Treponema pallidum (TRUSTwell ) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with Tp.
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