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Product Documentation

  • Avioq HTLV-I/II
  • Avioq HIV-1
  • VioOne Sample Collection Device
  • VioOne HIV Profile

CategoryFile Name
Package InsertAvioq HTLV - I/II Package Insert
SDS Sheets559879 559880 Wash Buffer Concentrate SDS
500192 500576 509600 Avioq HTLV-I-II Microelisa SDS
Stop SolutionAvioq Stop Solution Recommendations, 2-2019
Registraton with FDALink to FDA.gov website for Approval of Avioq HTLV-I/II Microelisa System
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 CertificationAvioq's Quality Management System Certification to MDSAP 672217
ISO 13485:2016 FM 581773 CertificationAvioq's Quality Management System ISO 13485_2016 FM 581773

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 FDAApproval of Avioq HIV-1 Micoelisa System

General Use PI for VioOne Sample Collection Device

CategoryFile Name
Package Insert43-01901 VioOne HIV Profile Supplemental Assay Package Insert (US)
43-01904 VioOne HIV Profile Supplemental Assay CE
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

Avioq, Inc.

104 T.W. Alexander Drive

Research Triangle Park

North Carolina, 27709

United States

Phone: 1.919.314.5535

Email: [email protected]

Products

• Avioq HTLV I/II

 

• Avioq HIV-1

 

• VioOne HIV Profile

 

• VioOne Sample Collection Device

 

• GMP Recombinant Proteins

Services

• IVD Assay Development

 

• IVD Contract Manufacturing

 

• Cell Culture Development

 

• Lab Space for Rent

Contact Us

 

About Avioq

 

Support

 

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