Product Documentation

• Avioq HTLV-I/II
• Avioq HIV-1
• VioOne HIV Profile

Category	File Name
Package Insert	Avioq HTLV - I/II Package Insert
SDS Sheets	559879 559880 Wash Buffer Concentrate SDS
	500192 500576 509600 Avioq HTLV-I-II Microelisa SDS
Stop Solution	Avioq Stop Solution Recommendations, 2-2019
Registration with FDA	External 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 Mark	EC Certificate - Full Quality Assurance Certificate History CE 581998
	EC Design-Examination Certificate CE582807
Health Canada	Avioq's Health Canada License 98368
ISO 13485 Certification	MDSAP 672217 Avioq's Quality Managment Certificate
ISO 13485:2016 FM 581773 Certification	FM 581773 Avioq's Quality Management System ISO 13485_2016

Category	File Name
Package Insert	Avioq HIV-1 Package Insert
SDS Sheets	100384,100960 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 FDA	Approval of Avioq HIV-1 Micoelisa System

Category	File Name
Package Insert	43-01901 VioOne HIV Profile Supplemental Assay Package Insert (US)
	43-01904 VioOne HIV Profile Supplemental Assay CE
Registration with FDA	External Link to FDA website for Approval of VioOne HIV Profile Supplemental Assay
Stop Solution	Avioq Stop Solution Recommendations, 2-2019
CE Mark	CE 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 Sheets	SDS - Wash Concentrate VioOne HIV Profile
	EU 700024 SDS Avioq VioOne HIV Profile Supplemental Assay
	400024 SDS Avioq VioOne HIV Profile Supplemental Assay