Alexon, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Alexon, Inc. makes
Alexon, Inc. manufactures diagnostic assays for detecting *Giardia* and *Cryptosporidium* parasites, including microplate-based tests and rapid lateral-flow assays. Their products include both screening tests and modifications for enhanced sensitivity, alongside control reagents for assay validation.
The company’s portfolio includes devices classified as Class I (general controls) and Class II (special controls), with submissions recorded under the FDA’s 510(k) pathway. Products are listed in the U.S. regulatory registry.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Prospect(Tm/Cryptosporidium Ref K912242
Regimes: 510(k) Registry: 510(k)Prospect Microplate Assay Ref K934493
Regimes: 510(k) Registry: 510(k)Prospec T/Giardia Rapid Assay Ref K911337
Regimes: 510(k) Registry: 510(k)Prospect(Tm) Giardia Rapid Assay, Modification Ref K931147
Regimes: 510(k) Registry: 510(k)Modification Prospect Giardia Rapid Assay Ref K920817
Regimes: 510(k) Registry: 510(k)Prospec T Giardia Microtiter Assay Ref K930451
Regimes: 510(k) Registry: 510(k)Prospect Giardia Ref K942098
Regimes: 510(k) Registry: 510(k)Prospect(Tm) Giardia Rapid Assay Ref K915093
Regimes: 510(k) Registry: 510(k)Prospect Giardia Controls Ref K922675
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alexon, Inc. have in the registry?
The registry currently lists 10 devices for Alexon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alexon, Inc.'s devices?
Among its 10 most recently registered devices, Alexon, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Alexon, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Alexon, 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, Inc. in the registry?
The most recently registered devices listed for Alexon, Inc. include PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION, PROSPECT(TM/CRYPTOSPORIDIUM, PROSPECT MICROPLATE ASSAY and PROSPEC T/GIARDIA RAPID ASSAY.