Bio-Probe, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Bio-Probe, Inc. makes
Bio-Probe, Inc. manufactures the CLEAN UP device, a product designed for medical decontamination or cleaning applications, and the BIOCALEX 6/9, a diagnostic reagent or calibration solution used in laboratory settings for microbiological testing or analysis.
The company’s portfolio includes Class I and Class II devices, all of which are subject to FDA 510(k) clearance requirements. These products are listed under the U.S. regulatory framework and are based in the United States.
Catalogue
Clean Up Ref K922985
Regimes: 510(k) Registry: 510(k)Biocalex 6/9 Ref K941532
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Probe, Inc. have in the registry?
The registry currently lists 2 devices for Bio-Probe, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Probe, Inc.'s devices?
Among its 2 most recently registered devices, Bio-Probe, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bio-Probe, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bio-Probe, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Probe, Inc. in the registry?
The most recently registered devices listed for Bio-Probe, Inc. include CLEAN UP and BIOCALEX 6/9.