Prodesse, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Prodesse, Inc. makes
Prodesse, Inc. manufactures immunoassay devices for detecting respiratory and gastrointestinal pathogens, including tests for influenza, human metapneumovirus (HMPV), and gastrointestinal infections. Their portfolio includes rapid diagnostic assays for point-of-care or laboratory use, designed to identify specific viral and bacterial targets in clinical samples.
The company’s assays are regulated under FDA’s Class I and Class II device classifications, with submissions supported via the 510(k) pathway. These products are listed in the FDA’s 510(k) database and are based in the United States.
Catalogue
Modification To Proflu+ Assay Ref K081030
Regimes: 510(k) Registry: 510(k)Proparaflu+assay Ref K091053
Regimes: 510(k) Registry: 510(k)Pro Hmpv+ Assay Ref K082688
Regimes: 510(k) Registry: 510(k)Progastro Cd Assay Ref K090239
Regimes: 510(k) Registry: 510(k)Proflu+ Assay Ref K073029
Regimes: 510(k) Registry: 510(k)Modification To Proflu+ Assay Ref K092500
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Prodesse, Inc. have in the registry?
The registry currently lists 6 devices for Prodesse, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prodesse, Inc.'s devices?
Among its 6 most recently registered devices, Prodesse, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Prodesse, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Prodesse, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prodesse, Inc. in the registry?
The most recently registered devices listed for Prodesse, Inc. include MODIFICATION TO PROFLU+ ASSAY, PROPARAFLU+ASSAY, PRO HMPV+ ASSAY and PROGASTRO CD ASSAY.