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U.S. Department of Health and Human Services

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.
 

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