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Vaccines, Blood & Biologics
Trinity Biotech Uni-Gold Recombigen HIV Uni-Gold Recombigen HIV Positive and Negative Controls
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
Label - Uni-Gold Recombigen HIV (PDF - 85 KB) )
Label - Uni-Gold Recombigen HIV Positive and Negative Controls (PDF - 42 KB)
Summary of Safety and Effectiveness (PDF - 122 KB)
Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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