Polysciences, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 2518071
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
What Polysciences, Inc. makes
Polysciences, Inc. manufactures diagnostic kits for microbiological testing, including the T3 STI Kit for sexually transmitted infection detection and the Fungi Fluor Kit for fungal pathogen identification. The company also produces the Centricell™, a cell culture product used in laboratory research and testing applications.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) clearance registry. These products are developed and distributed from the company’s U.S. headquarters.
Catalogue
T3 Sti Kit Ref K780146
Regimes: 510(k) Registry: 510(k)Centricell(Tm) Ref K871290
Regimes: 510(k) Registry: 510(k)Fungi Fluor Kit Ref K923349
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 2518071
- Address
- 400 VALLEY RD., WARRINGTON, PA, 18976
Frequently asked questions
How many devices does POLYSCIENCES, INC. have in the registry?
The registry currently lists 3 devices for POLYSCIENCES, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list POLYSCIENCES, INC.'s devices?
Among its 3 most recently registered devices, POLYSCIENCES, INC. has devices listed in FDA 510(k) (3 devices).
What risk classes do POLYSCIENCES, INC.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for POLYSCIENCES, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from POLYSCIENCES, INC. in the registry?
The most recently registered devices listed for POLYSCIENCES, INC. include T3 STI KIT, CENTRICELL(TM) and FUNGI FLUOR KIT.