Friday, December 9, 2022

Gentueri Inc. Receives FDA Facility Registration and Device Listing

December 14, 2020

Gentueri Inc., a crisis innovator leading in the fight against COVID-19, received confirmation of its FDA Facility Registration and Device Listing.

Gentueri Inc, founded by Randy Nagy in 2012, specializes in advancing the collection, preservation, and processing of biological samples with innovative devices and kits.

Historically, Gentueri has provided DNA collection kits to the forensic market, launching some of the most innovative DNA collection devices in the market. But shortly after the COVID-19 crisis began, Gentueri pivoted sharply. Recognizing the threat early on, the company extended its production to include COVID-19 test kits.

The new facility is four times the size of its previous location and will allow the company to increase capacity, expedite orders, add new innovative products, and serve customers with quality products.

Randy Nagy, founder of Gentueri commented, “Obtaining FDA Registration of our new larger facility represents an important step in our expansion plans as we significantly increase capacity and meet the requirements of new medical device markets. We are also proud to continue our fight against COVID-19 with our new product listings for Viral Transport Media Kits and our PBS Response Kit.”

In compliance with the Unique Device Identification (UDI) requirements, the company is now approved by the FDA to manufacture and distribute both its Viral Transport Media Kits (VTM) and PBS Response Kits. The kits are helping to facilitate COVID-19 testing for residents across the state of Wisconsin as well as neighboring states.

Gentueri plans to use their new, larger medical device facility to expand its ability to fight COVID-19, enter new markets and design innovative biospecimen collection devices that collect samples easily and preserve them at room temperature, enabling convenient integration into downstream automated analytical systems.

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