Uni-Gold Recombigen HIV-1/2

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

• 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).

Product Information

• Package Insert - Uni-Gold Recombigen HIV-1/2

Supporting Documents

• February 4, 2013 Approval Letter - Uni-Gold Recombigen HIV-1/2
• Letter - Trinity Biotech Uni-Gold Recombigen HIV, Uni-Gold Recombigen HIV Positive and Negative Controls - ARCHIVED
• Summary of Safety and Effectiveness - Uni-Gold Recombigen HIV - ARCHIVED