Vitek Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 39
What Vitek Systems, Inc. makes
Vitek Systems, Inc. manufactures in vitro diagnostic devices including identification cards for gram-positive bacteria, immunodiagnostic assay systems such as VIDAS for detecting infectious agents and biomarkers, calibrator kits for drugs like procainamide and anticonvulsants, and reagent kits such as SLIDEX ROTA-KIT 2 and RAPID CORYNE SYST for bacterial identification.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Vitek Systems, Inc. is based in the United States.
Catalogue
Search and filter all 39 devicesFrequently asked questions
How many devices does Vitek Systems, Inc. have in the registry?
The registry currently lists 39 devices for Vitek Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vitek Systems, Inc.'s devices?
Among its 39 most recently registered devices, Vitek Systems, Inc. has devices listed in FDA 510(k) (39 devices).
What risk classes do Vitek Systems, Inc.'s devices fall under?
Among its 39 most recently registered devices, the classes recorded for Vitek Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vitek Systems, Inc. in the registry?
The most recently registered devices listed for Vitek Systems, Inc. include AMS GRAM-POSITIVE IDENT. CARD, VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG), PROCAINAMIDE CALIBRATOR KIT and VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY.