California Integrated Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What California Integrated Diagnostics, Inc. makes
California Integrated Diagnostics, Inc. manufactures in vitro diagnostic tests for sexually transmitted infections, including enzyme immunoassays for *Trichomonas vaginalis* detection and specimen test kits for *Chlamydia trachomatis*. Their portfolio also includes typing assays for *Herpes simplex virus* via tissue culture confirmation.
These diagnostic devices are classified as Class I or Class II under FDA regulations and are submitted for clearance via the 510(k) pathway. The company is based in the United States.
Catalogue
Trichomonas Direct Enzyme Immunoassay Ref K874259
Regimes: 510(k) Registry: 510(k)Modified Chlamydia Direct Specimen Test Kit Ref K871278
Regimes: 510(k) Registry: 510(k)Herpes Simplex Virus Tissue Culture Conf. Typing Ref K904095
Regimes: 510(k) Registry: 510(k)Modified Trichomonas Direct Specimen Test Kit Ref K871279
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does California Integrated Diagnostics, Inc. have in the registry?
The registry currently lists 4 devices for California Integrated Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list California Integrated Diagnostics, Inc.'s devices?
Among its 4 most recently registered devices, California Integrated Diagnostics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do California Integrated Diagnostics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for California Integrated Diagnostics, 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 Integrated Diagnostics, Inc. in the registry?
The most recently registered devices listed for California Integrated Diagnostics, Inc. include TRICHOMONAS DIRECT ENZYME IMMUNOASSAY, MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT, HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING and MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT.