Serex, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Serex, Inc. makes
Serex, Inc. manufactures immunoassay devices for detecting specific biomarkers, including automated and manual versions of the COMA cocaine metabolite assay and the beta-2 microglobulin EIA test.
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
Automates Coma Cocaine Metabolite Assay Ref K921834
Regimes: 510(k) Registry: 510(k)Coma Cocaine Metabolite Assay (Eia) Ref K895043
Regimes: 510(k) Registry: 510(k)Beta-2 Microglobulin Eia Ref K901333
Regimes: 510(k) Registry: 510(k)Beta-2 Microglobulin Eia Ref K890694
Regimes: 510(k) Registry: 510(k)Automates Coma Plus Cocaine Metabolite Assay Ref K923314
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Serex, Inc. have in the registry?
The registry currently lists 5 devices for Serex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Serex, Inc.'s devices?
Among its 5 most recently registered devices, Serex, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Serex, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Serex, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Serex, Inc. in the registry?
The most recently registered devices listed for Serex, Inc. include AUTOMATES COMA COCAINE METABOLITE ASSAY, COMA COCAINE METABOLITE ASSAY (EIA), BETA-2 MICROGLOBULIN EIA and AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY.