Abtox, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Abtox, Inc. makes
Abtox, Inc. manufactures biological indicators and process monitors for sterilization validation, including the PLAZLYTE™ sterilization process biological indicator and the ABTOX PLAZLYTE PROCESS MONITOR, designed to assess sterilization efficacy in medical device manufacturing.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Plazlyte(Tm) Ref K905119
Regimes: 510(k) Registry: 510(k)Abtox Plazlyte Process Monitor Ref K923442
Regimes: 510(k) Registry: 510(k)Abtox Serilization Process Biological Indicator Ref K923739
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Abtox, Inc. have in the registry?
The registry currently lists 3 devices for Abtox, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abtox, Inc.'s devices?
Among its 3 most recently registered devices, Abtox, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Abtox, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Abtox, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Abtox, Inc. in the registry?
The most recently registered devices listed for Abtox, Inc. include PLAZLYTE(TM), ABTOX PLAZLYTE PROCESS MONITOR and ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR.