Alexon Biomedical, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Alexon Biomedical, Inc. makes
Alexon Biomedical, Inc. manufactures diagnostic microplate assays and rapid tests for detecting intestinal parasites and toxins, including *Entamoeba histolytica*, *Giardia*, *Cryptosporidium*, and *Clostridium difficile* toxin A.
Their products are regulated as Class I and Class II devices under FDA 510(k) clearance, and the company is based in the United States.
Catalogue
Prospect Entamoeba Histolytica Microplate Assay Ref K933997
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Prospect Cryptosporidium Rapid Assay Ref K936191
Regimes: 510(k) Registry: 510(k)Prospect/Giardia Ref K874849
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alexon Biomedical, Inc. have in the registry?
The registry currently lists 5 devices for Alexon Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alexon Biomedical, Inc.'s devices?
Among its 5 most recently registered devices, Alexon Biomedical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Alexon Biomedical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Alexon Biomedical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alexon Biomedical, Inc. in the registry?
The most recently registered devices listed for Alexon Biomedical, Inc. include PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY, PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY, PROSPECT CRYPTOSPORIDIUM RAPID ASSAY and PROSPECT/GIARDIA.