Avioq
Avioq specializes in the development, production, and distribution of in-vitro diagnostic medical devices and offers contract development and manufacturing services in an FDA licensed and ISO 13485 certified environment.
Services
Avioq specializes in the development, production, and distribution of in-vitro diagnostic (IVD) medical devices. The company provides flexible contract development and manufacturing services in an FDA licensed and ISO 13485 certified environment. These services include IVD Assay Development, IVD Contract Manufacturing, and Cell Culture Development. They also offer bio-manufacturing and analytical capabilities, including recombinant protein production in mammalian or bacterial cells and monoclonal antibodies.
Products
Avioq's product portfolio includes several key diagnostic assays and biomedical products. Among these are the Avioq HTLV-I/II Microelisa System, an ELISA for qualitative detection of antibodies to HTLV-I/II; the Avioq HIV-1 Microelisa System for detecting HIV-1 antibodies; and the VioOne HIV Profile Supplemental Assay for confirmation and differentiation of HIV-1 and HIV-2 antibodies. The company also offers GMP Recombinant Proteins and Synthetic Peptides, which are used in FDA Approved/Licensed IVD Immunoassays.
FDA and CE Approved Diagnostic Assays
Avioq's diagnostic assays have received important regulatory approvals. The Avioq HTLV-I/II Microelisa System is FDA licensed and CE marked for screening serum and plasma from blood donor and cadaveric samples. The Avioq HIV-1 Microelisa System has FDA approval for testing serum, plasma, dried blood spots, and oral fluid specimens. The VioOne HIV Profile Supplemental Assay has received both FDA approval and CE marking.
Certified Manufacturing Facility
Avioq operates its manufacturing facility in Research Triangle Park, North Carolina. The facility is FDA (BLA) licensed and ISO 13485:2016 certified, ensuring it meets high-quality manufacturing standards. It includes a Bio Safety Level 2 facility for large-scale virus production, providing the necessary environment for complex bio-manufacturing tasks.
Conference Participation
Avioq actively participates in industry conferences to stay current with the latest developments and innovations in the field of in-vitro diagnostics. The company has attended various conferences such as the 2023 APHL ID Lab Conference, the 2022 APHL Annual Conference, and the 2022 ASM Clinical Virology Symposium.