Vaccines, Blood & Biologics

UltraQual HBV PCR Assay

STN: BL 125193
Proper Name: Hepatitis B Virus (Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic)
Tradename: UltraQual™ HBV PCR Assay
Manufacturer: National Genetics Institute
Indication: for the qualitative detection of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) in individual or pooled samples of human Source Plasma (or plasma samples obtained from Source Plasma donors at the time of donation). 

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

Page Last Updated: 02/28/2018
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