HIV-Ab/Ag 4th Gen Rapid Test - India CDSCO Medical Device Registration

HIV-Ab/Ag 4th Gen Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_2a609ef9d8b1e977909dde8a8d224e27_83e4f63a398ee9dd2e1f8fb80856f39a. 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

HIV-Ab/Ag 4th Gen Rapid Test

UID: MFG/IVD/2020/000046_2a609ef9d8b1e977909dde8a8d224e27_83e4f63a398ee9dd2e1f8fb80856f39a

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 HIV - Ab/Ag 4th Gen Rapid Test is intended for use by healthcare professionals and a rapid, qualitative, screening lateral flow chromatographic immunoassay for the simultaneous detection & differentiation of HIV-1 & HIV-2 antibodies (TRUSTline) in human serum, plasma or whole blood. The test kit is not automated and does not require any additional instrument. Any reactive specimen with the TRUSTline HIV- Ab/Ag 4th Gen Rapid Test must be confirmed with alternative testing method(TRUSTline) such as ELISA, Western Blot assay or PCR and clinical findings

Class D

HCV Ab Rapid Test

Brand: TRUSTline

Athenese-Dx Private Limited

Class D

Brand: TRUSTline

Class D