Progene Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Progene Corp. makes
Progene Corp. manufactures diagnostic tests for detecting microalbuminuria and measuring immunoglobulin E (IgE) levels, including a microalbuminuria screening device and two IgE assay formats: a bead-based enzyme immunoassay (EIA) and a standalone IgE test.
The company’s products are regulated under FDA’s Class I and Class II categories, with relevant devices listed via the 510(k) pathway. These devices are intended for in vitro diagnostic use and are based in the United States.
Catalogue
Progene Microalbuminuria Screen Ref K882538
Regimes: 510(k) Registry: 510(k)Progene(Tm) Ige Test Ref K875125
Regimes: 510(k) Registry: 510(k)Progene Ige Bead Eia Ref K895294
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Progene Corp. have in the registry?
The registry currently lists 3 devices for Progene Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Progene Corp.'s devices?
Among its 3 most recently registered devices, Progene Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Progene Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Progene Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Progene Corp. in the registry?
The most recently registered devices listed for Progene Corp. include PROGENE MICROALBUMINURIA SCREEN, PROGENE(TM) IGE TEST and PROGENE IGE BEAD EIA.