Our Product Expertise
Our R&D, quality and manufacturing teams have successfully designed and developed numerous medical diagnostic products during the past 25 years.
Put that experience to work to get your product to the marketplace as quickly as possible.
Who We Are
Avioq is an in vitro diagnostic medical device manufacturer and a contract development, contract manufacturing organization. Based in Research Triangle Park, North Carolina, Avioq has a FDA licensed manufacturing facility and large, modern R&D laboratories.
Our R&D, quality and manufacturing teams have successfully designed and developed numerous medical diagnostic products during the past 25 years. Put that experience to work to get your product to the marketplace as quickly as possible.
Our products include an FDA licensed HTLV-I/II assay for screening serum and plasma from blood donor and cadaveric samples, which also has CE marking and Health Canada approval.
The Avioq HIV-1 assay is the only product with FDA approved claims for testing serum, plasma, dried blood spots, and oral fluid specimens.
The FDA approved HIV Profile™ assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma. It is intended as an additional, more specific test to confirm the presence of antibodies in specimens repeatedly reactive in diagnostic procedures.
The CE Mark version can also be used in epidemiological studies to distinguish recent from longstanding HIV-1 infection for incidence estimation.
Instead of using consultants who talk about the regulatory process we actually live it. We develop and manufacture our own FDA and CE Mark products to the highest standards.
The manufacturing facility is FDA (BLA) licensed and ISO 13485:2016 certified.
Need a quick answer? We can help you with proof of concept projects, feasibility studies, research lots, and more.
If you entrust your project to Avioq, we will focus on getting your product through our mature Quality System, approvable by Regulatory Authorities, manufactured and to market as quickly as possible. Our team will guide you past the regulatory delays and pitfalls.
Assay Development
When you use our proven quality system and development process, your IVD project will benefit from the fastest, most streamlined path through manufacture, approval, and to market.
Contact Us
Call Jeff Sides at 919.314.5535 or infor@avioq.com. You can also fill out the form below and we will be in contact with you as soon as possible.