HIV 1+2 Ab ELISA Kit - India CDSCO Medical Device Registration

HIV 1+2 Ab ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000038_3957999cda3f4fae5c065b1cb0be1feb_c315bf7943eaab37242f3a785ee63408. 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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CDSCO Registered

Class Class D

HIV 1+2 Ab ELISA Kit

UID: MFG/IVD/2020/000038_3957999cda3f4fae5c065b1cb0be1feb_c315bf7943eaab37242f3a785ee63408

Brand Name

TRUSTwell

License Holder

Athenese-Dx Private Limited

Device Class

Class D

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The HIV 1+2 Ab ELISA Kit is a solid phase enzyme linked immunoabsorbent assay for the qualitative detection of anti-HIV-1 including subtype O and anti-HIV-2 antibodies (TRUSTwell) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with HIV-1 and HIV-2 viruses. Any reactive specimen with the HIV 1+2 Ab ELISA Kit must be confirmed with alternative testing method(TRUSTwell) and clinical findings

Class D

Brand: TRUSTline

Class D