Vaccines, Blood & Biologics

Uni-Gold Recombigen HIV-1/2

PMA: BP030025
Manufacturer: Trinity Biotech
Tradename: Uni-Gold™ Recombigen® HIV-1/2

  • Indicated as a single use rapid immunoassay for the qualitative detection of antibodies to HIV-1 and/or HIV-2 in human serum, plasma and whole blood (venipuncture and fingerstick).


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 07/24/2018
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