Avioq

Description

• Avioq, Inc., founded in 2007 and incorporated in North Carolina, has headquarters in Research Triangle Park, NC. The Management Team is comprised of 9 individuals (6 PhDs) with over 250 years of experience in the diagnostics industry. The companys current products include an FDA approved HIV-1 assay (a Class III device), an FDA licensed HTLV-I/II assay for blood donor screening (currently distributed by OCD), which has also been CE-marked and approved by Health Canada, as well as three other CE Marked products including a homogeneous biochemiluminescence based Flu A/B diagnosis test, a rapid influenza virus drug resistance test and an Oral fluid collection device. In addition, the company has two other HIV products in development ready for field testing, a 4th Gen HIV test and an HIV Profile assay for the detection and estimation of antibody levels directed to different gene products of HIV-1 and HIV-2. The company also offers contract research and contract manufacturing for diagnostic test kits and critical biomaterials to third parties.Our manufacturing facility is FDA (BLA) licensed and ISO 13485 certified. The facility includes a Bio Safety Level 2 facility for large scale viral lysate production, a suite for production of recombinant antigens produced either in mammalian cells or bacterial cells, a multi-room suite for production of kit components, an area for kit assembly, a QC laboratory, several walk-in refrigeration rooms, and warehouse areas for receiving, quarantining and storage of raw materials.Avioqs Design Control and Quality Systems are fully developed. Our facility has been inspected numerous times by FDA and ISO, as well as by external partners. We are compliant with FDA 21 CFR Part 820 and ISO 13485 requirements for document and purchasing controls, complaint handling, CAPA, non-conformances, design/production/process controls, quality audits, risk management and training.
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  Headquarters:104 Tw Alexander Dr , Rtp, North Carolina, United States

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  Phone Number: +1 919-314-5535

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  Website: https://www.avioq.com

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  Employees:30

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  Revenue:$10 - 50M

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  Legal Name:Avioq

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• |  NAICS Code: 325412  |

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