PMA #: BP180279
Applicant: Avioq, Inc.
Product: VioOne HIV Profile Supplemental Assay
Indication for Use:
- The VioOne™ HIV Profile™ Supplemental Assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to Human Immunodeficiency Virus Type 1 (HIV-1 Group M & Group O) and Type 2 (HIV-2) in human serum or plasma. The VioOne™ HIV Profile™ Supplemental Assay is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. It is intended as an additional, more specific test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens repeatedly reactive in diagnostic procedures, including pediatric patients (ages 2-20).
- This device is not intended for use as a first line diagnostic test or for screening donors of blood, blood products, or human cells or tissues or cellular and tissue-based products (HCT/Ps).
Approval Date: 10/19/2020
- Summary of Safety and Effectiveness - VioOne HIV Profile Supplemental Assay
- October 19, 2020 Approval Order - VioOne HIV Profile Supplemental Assay