Bioanalytical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Bioanalytical Systems, Inc. makes
Bioanalytical Systems, Inc. manufactures diagnostic test kits for measuring urinary and plasma catecholamines, including metanephrine levels. These kits are designed for laboratory use to support the detection and monitoring of conditions related to catecholamine metabolism.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are based in the United States.
Catalogue
Urinary Metanephrine Kit Ref K952919
Regimes: 510(k) Registry: 510(k)Plasma Catecholamine Kit Ref K972167
Regimes: 510(k) Registry: 510(k)Urinary Catecholamine Kit Ref K943099
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioanalytical Systems, Inc. have in the registry?
The registry currently lists 3 devices for Bioanalytical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioanalytical Systems, Inc.'s devices?
Among its 3 most recently registered devices, Bioanalytical Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bioanalytical Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bioanalytical Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Bioanalytical Systems, Inc. in the registry?
The most recently registered devices listed for Bioanalytical Systems, Inc. include URINARY METANEPHRINE KIT, PLASMA CATECHOLAMINE KIT and URINARY CATECHOLAMINE KIT.