Corgenix, Inc.
United StatesFDA applicant, unverified FDA FEI 1000117401
- Devices
- 23
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Corgenix, Inc. makes
Corgenix, Inc. manufactures semi-quantitative and quantitative test kits for detecting specific autoantibodies, including anti-phosphatidylserine (IgG/IgM/IgA), anti-cardiolipin (IgG/IgM), anti-β2-glycoprotein I (IgG/IgA), anti-prothrombin, anti-dsDNA, and anti-atherox. The company also produces diagnostic systems for Hepatitis A antibodies (Hep-ANA) and kits for measuring IgG/IgM anti-β2-glycoprotein I levels.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Search and filter all 23 devicesCompany details
- FDA FEI number
- 1000117401
- Address
- 11575 MAIN ST., BROOMFIELD, CO, 80020
Frequently asked questions
How many devices does Corgenix, Inc. have in the registry?
The registry currently lists 23 devices for Corgenix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Corgenix, Inc.'s devices?
Among its 23 most recently registered devices, Corgenix, Inc. has devices listed in FDA 510(k) (23 devices).
What risk classes do Corgenix, Inc.'s devices fall under?
Among its 23 most recently registered devices, the classes recorded for Corgenix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Corgenix, Inc. in the registry?
The most recently registered devices listed for Corgenix, Inc. include REAADS IGG ANTI-B2GPI TEST KIT, MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT, REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT and REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT.