Cyberfluor, Inc.
CanadaFDA 510(k) applicant, unverified
- Devices
- 17
What Cyberfluor, Inc. makes
Cyberfluor, Inc. manufactures time-resolved fluoroimmunoassay kits and automated immunoanalyzers for measuring hormone and protein levels in clinical samples. Their products include assays for ferritin, thyroid hormones (T3, T4, TSH), prolactin, human growth hormone (HGH), digoxin, and rubella IgG, as well as specialized kits for conditions like hemolytic anemia (HLH.S) and tuberculosis (TBG). The company also supplies standalone analyzers designed to process these assays in laboratory settings.
The portfolio consists of Class I and Class II devices under FDA regulations, with several products cleared via the 510(k) pathway. These assays and analyzers are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Search and filter all 17 devicesFrequently asked questions
How many devices does Cyberfluor, Inc. have in the registry?
The registry currently lists 17 devices for Cyberfluor, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cyberfluor, Inc.'s devices?
Among its 17 most recently registered devices, Cyberfluor, Inc. has devices listed in FDA 510(k) (17 devices).
What risk classes do Cyberfluor, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Cyberfluor, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cyberfluor, Inc. in the registry?
The most recently registered devices listed for Cyberfluor, Inc. include FIAGEN FERRITIN, FIAGEN(TM) HLH.S, FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT and FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201.