HIV Ag-Ab ELISA Kit - India CDSCO Medical Device Registration

HIV Ag-Ab ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000053_a06b1927c12397eef48eb4bb09b30281_c1288fe715f04ca99fc06cc5eb0b8d38. This device is marketed under the brand name HBsAg ELISA Kit, Labsystems Diagnostics . The license holder is Trivitron Healthcare Pvt. Ltd, 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 Ag-Ab ELISA Kit

UID: MFG/IVD/2020/000053_a06b1927c12397eef48eb4bb09b30281_c1288fe715f04ca99fc06cc5eb0b8d38

Brand Name

HBsAg ELISA Kit, Labsystems Diagnostics

License Holder

Trivitron Healthcare Pvt. Ltd

Device Class

Class D

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

HIV Ag-Ab ELISA Kit is an 4th generation in vitro diagnostic immunoassay for the qualitative determination of antigens & antibodies to HIV-1, HIV-1 & Ag-P24 group O, and HIV-2 in human serum or plasma. The kit is basically intended to screen blood donation samples to identify and eliminate the infected units of blood and for clinical diagnostic testing