Qualisys Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Qualisys Diagnostics, Inc. makes
Qualisys Diagnostics, Inc. makes the FASTPACK PSA Immunoassay and the FASTPACK System, which are in vitro diagnostic devices used for prostate-specific antigen testing.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Fastpack Psa Immunoassay, Fastpack System Ref K994419
Regimes: 510(k) Registry: 510(k)Qualisys Psa Immunoassay Ref K990234
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Qualisys Diagnostics, Inc. have in the registry?
The registry currently lists 2 devices for Qualisys Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qualisys Diagnostics, Inc.'s devices?
Among its 2 most recently registered devices, Qualisys Diagnostics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Qualisys Diagnostics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Qualisys Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Qualisys Diagnostics, Inc. in the registry?
The most recently registered devices listed for Qualisys Diagnostics, Inc. include FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM and QUALISYS PSA IMMUNOASSAY.