Bard Diagnostic Sciences, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Bard Diagnostic Sciences, Inc. makes
Bard Diagnostic Sciences, Inc. manufactures urine-based diagnostic tests for bladder tumor detection, including the BARD AND BTA TEST, BTA STAT TEST for prescription home use, and the BARD BTA TRAK TEST. These tests detect bladder tumor antigens to aid in monitoring and diagnosing bladder cancer.
The company’s portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) clearance process. These products are listed under the US regulatory framework and are intended for use in clinical settings and home testing environments.
Catalogue
Bard And Bta Test Ref K964151
Regimes: 510(k) Registry: 510(k)Bta Stat Test Prescription Home Use Ref K974845
Regimes: 510(k) Registry: 510(k)Bard Bta Trak Test Ref K971402
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bard Diagnostic Sciences, Inc. have in the registry?
The registry currently lists 3 devices for Bard Diagnostic Sciences, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bard Diagnostic Sciences, Inc.'s devices?
Among its 3 most recently registered devices, Bard Diagnostic Sciences, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bard Diagnostic Sciences, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bard Diagnostic Sciences, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bard Diagnostic Sciences, Inc. in the registry?
The most recently registered devices listed for Bard Diagnostic Sciences, Inc. include BARD AND BTA TEST, BTA STAT TEST PRESCRIPTION HOME USE and BARD BTA TRAK TEST.