Product Documentation Avioq HTLV-I/II Avioq HIV-1 VioOne HIV Profile CategoryFile Name Package Insert43-01800 Package Insert US HTLV-I_II IVD_Rev-4.12 43-01809 Package Insert CE HTLV-I_II IVD_Rev-4.12 SDS Sheets559879 559880 Wash Buffer Concentrate SDS 500192 500576 509600 Avioq HTLV-I-II Microelisa SDS Stop SolutionAvioq Stop Solution Recommendations, 2-2019 Registration with FDAExternal Link to FDA website for Approval of Avioq HTLV-I/II EIA/Lysate Complete List of Donor Screening Assays for Infectious Agents Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases Avioq HTLV SBRA Final March 26 2012 US License No 1856 [PDF] March 26, 2012 FDA Approval Letter-Avioq HTLV-I II US License No 1856 [PDF] CE MarkEC Certificate - Full Quality Assurance Certificate History CE 581998 EC Design-Examination Certificate CE582807 Health CanadaAvioq's Health Canada License 98368 ISO 13485 CertificationMDSAP 672217 Avioq's Quality Managment Certificate ISO 13485:2016 FM 581773 CertificationFM 581773 Avioq's Quality Management System ISO 13485_2016 CategoryFile Name Package InsertAvioq HIV-1 Package Insert SDS Sheets100384,100960 and 109600 Avioq HIV-1 Microelisa System SDS 250625, 250626 DBS Dilution Medium SDS 250620 and 250622 Wash Concentrate 50X for Avioq HIV-1 Microelisa System SDS Registration with FDAExternal Link to FDA website for Approval of Avioq HIV-1 Micoelisa System CategoryFile Name Package Insert43-01901 VioOne HIV Profile Supplemental Assay Package Insert (US) 43-01904 VioOne HIV Profile Supplemental Assay CE Registration with FDAExternal Link to FDA website for Approval of VioOne HIV Profile Supplemental Assay Stop SolutionAvioq Stop Solution Recommendations, 2-2019 CE MarkCE 581998 EC Certificate - Full Quality Assurance Scope Change_HIV 1 and HIV 2 Supplemental Antibody Test Kits CE 691829 EC Design Examination Certificate VioOne HIV Profile SDS SheetsSDS - Wash Concentrate VioOne HIV Profile EU 700024 SDS Avioq VioOne HIV Profile Supplemental Assay 400024 SDS Avioq VioOne HIV Profile Supplemental Assay