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Vaccines, Blood & Biologics
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UltraQual HIV-1 RT-PCR Assay
Proper Name: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay
Tradename: UltraQual HIV-1 RT-PCR Assay
Manufacturer: National Genetics Institute, License #1582
Indication:
- Qualitative detection of human immunodeficiency virus type 1(HIV-1) of ribonucleic acid (RNA) in pooled human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples.
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Supporting Documents
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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