Cleveland Diagnostics, Inc.
United Statesfrom the FDA registration address FDA FEI 3011015335
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Cleveland Diagnostics, Inc. makes
Cleveland Diagnostics, Inc. manufactures the IsoPSA Assay, a diagnostic test designed to measure isofluent prostate-specific antigen (IsoPSA) levels in blood samples for prostate cancer detection and monitoring.
The company’s portfolio is regulated under FDA’s Class III designation, requiring a Premarket Approval (PMA). The IsoPSA Assay is listed in the FDA’s PMA registry. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
IsoPSA Assay Ref P200048
Regimes: PMA Registry: PMA
Company details
- FDA FEI number
- 3011015335
- DUNS number
- 080629312
- Address
- 3615 Superior Ave Ste 4406a, Cleveland, OH, 44114
- [email protected]
- Phone
- 18332656647
Frequently asked questions
How many devices does Cleveland Diagnostics, Inc. have in the registry?
The registry currently lists 3 devices for Cleveland Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cleveland Diagnostics, Inc.'s devices?
Among its 3 most recently registered devices, Cleveland Diagnostics, Inc. has devices listed in FDA PMA (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cleveland Diagnostics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cleveland Diagnostics, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Cleveland Diagnostics, Inc. in the registry?
The most recently registered devices listed for Cleveland Diagnostics, Inc. include IsoPSA Reagent P302, IsoPSA Controls P901 and IsoPSA Assay.