Premarket Approval Information - Devices
Applicant: Trinity Biotech plc, Wicklow, Ireland
Products: Trinity Biotech Uni-Gold Recombigen HIV, Uni-Gold Recombigen HIV Positive and Negative Controls
PMA number: BP030025 / 0
Indication for Use: Detection of antibodies to HIV-1 in human serum, plasma or whole blood (venipuncture) specimens
Approval Date: 12/23/2003
Letter -
(Text)
Label - Uni-Gold Recombigen HIV -
(PDF)
Label - Uni-Gold Recombigen HIV Positive and Negative Controls -
(PDF)
Summary of Safety and Effectiveness -
(PDF)
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