California Immuno Diagnostic, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What California Immuno Diagnostic, Inc. makes
California Immuno Diagnostic, Inc. manufactures diagnostic systems for detecting allergens and immune responses, including the ALKPHOR System for allergen-specific IgE testing, the AUTOFLUOR System for fluorescence-based immunoassays, and the DIA Strips System for rapid diagnostic testing.
These products are regulated under FDA’s 510(k) pathway as Class I and Class II devices, with listings in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Alkphor System Ref K823445
Regimes: 510(k) Registry: 510(k)Autofluor System Ref K800698
Regimes: 510(k) Registry: 510(k)Dia Strips System Ref K831623
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does California Immuno Diagnostic, Inc. have in the registry?
The registry currently lists 3 devices for California Immuno Diagnostic, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list California Immuno Diagnostic, Inc.'s devices?
Among its 3 most recently registered devices, California Immuno Diagnostic, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do California Immuno Diagnostic, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for California Immuno Diagnostic, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from California Immuno Diagnostic, Inc. in the registry?
The most recently registered devices listed for California Immuno Diagnostic, Inc. include ALKPHOR SYSTEM, AUTOFLUOR SYSTEM and DIA STRIPS SYSTEM.