Alidex, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Alidex, Inc. makes
Alidex, Inc. manufactures diagnostic test devices for detecting human chorionic gonadotropin (hCG) in urine and serum samples, including dipstick and quantitative assay formats.
These products are classified as Class II devices under FDA regulations and are authorised via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
Poly Stat Hcg Dipstick Test Ref K021386
Regimes: 510(k) Registry: 510(k)Poly Stat Serum/Urine Hcg Test Ref K030430
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alidex, Inc. have in the registry?
The registry currently lists 2 devices for Alidex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alidex, Inc.'s devices?
Among its 2 most recently registered devices, Alidex, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Alidex, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Alidex, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alidex, Inc. in the registry?
The most recently registered devices listed for Alidex, Inc. include POLY STAT HCG DIPSTICK TEST and POLY STAT SERUM/URINE HCG TEST.