Eragen Biosciences, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Eragen Biosciences, Inc. makes
Eragen Biosciences, Inc. manufactures the Multicode-RTX Herpes Simplex Virus 1 & 2 Kit, a diagnostic device designed for the detection of herpes simplex virus types 1 and 2.
This product is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- 510(k) 510(k)
Multicode-Rtx Herpes Simplex Virus 1 & 2 Kit Ref K111527
510(k) 510(k)
Frequently asked questions
How many devices does Eragen Biosciences, Inc. have in the registry?
The registry currently lists 2 devices for Eragen Biosciences, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eragen Biosciences, Inc.'s devices?
Among its 2 most recently registered devices, Eragen Biosciences, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Eragen Biosciences, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Eragen Biosciences, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Eragen Biosciences, Inc. in the registry?
The most recently registered devices listed for Eragen Biosciences, Inc. include MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 and MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT.