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).
Supporting Documents
- September 1, 2011 Approval Letter - UltraQual HBV PCR Assay
- Summary Basis for Regulatory Action - UltraQual HBV PCR Assay