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VioOne HIV Profile Supplemental Assay

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

Product Information

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