Focus Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Focus Technologies, Inc. makes
Focus Technologies, Inc. manufactures diagnostic immunoassay devices for detecting antibodies to specific pathogens, including ELISA tests for IgG and IgM markers. Their portfolio includes tests for herpes simplex viruses (HERPESELECT) and West Nile virus, designed for laboratory use to identify immune responses in patient samples.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Herpeselect 2 Elisa Igg, Model ELO920G Ref K021486
Regimes: 510(k) Registry: 510(k)West Nile Virus Elisa Igg, Model EL0300G Ref K031953
Regimes: 510(k) Registry: 510(k)West Nile Virus Igm Capture Elisa Ref K040854
Regimes: 510(k) Registry: 510(k)West Nile Virus Igm Capture Elisa, Model EL0300M Ref K031952
Regimes: 510(k) Registry: 510(k)Herpeselect 1 Elisa Igg, Model EL0910G Ref K021429
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Focus Technologies, Inc. have in the registry?
The registry currently lists 5 devices for Focus Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Focus Technologies, Inc.'s devices?
Among its 5 most recently registered devices, Focus Technologies, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Focus Technologies, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Focus Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Focus Technologies, Inc. in the registry?
The most recently registered devices listed for Focus Technologies, Inc. include HERPESELECT 2 ELISA IGG, MODEL ELO920G, WEST NILE VIRUS ELISA IGG, MODEL EL0300G, WEST NILE VIRUS IGM CAPTURE ELISA and WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M.