Ciba Corning Diagnostics Corp.
United StatesFDA applicant, unverified
- Devices
- 125
What Ciba Corning Diagnostics Corp. makes
The company produces immunoassay devices and laboratory controls for hormone and thyroid testing, including automated analyzers like the MAGIC LITE series for T4, LH, prolactin, and chlamydia detection, as well as the ACS FRT4 and ACS;180 DPD assays. It also manufactures electrolyte measurement systems such as CERTAIN LYTE and quality control sera like the GILFORD UNIQUAL ABNORMAL CONTROL SERUM. Rapid diagnostic tools, including the RAPIDQC PLUS, are part of its portfolio.
These devices are classified under Class I and Class II regulatory categories in the US, with submissions recorded via FDA 510(k) pre-market notifications. The company’s products are listed in the FDA’s regulatory database under this pathway. The manufacturer is based in the United States.
Catalogue
Search and filter all 125 devicesShowing 1-50 of 125
Frequently asked questions
How many devices does Ciba Corning Diagnostics Corp. have in the registry?
The registry currently lists 125 devices for Ciba Corning Diagnostics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ciba Corning Diagnostics Corp.'s devices?
Among its 50 most recently registered devices, Ciba Corning Diagnostics Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Ciba Corning Diagnostics Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ciba Corning Diagnostics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ciba Corning Diagnostics Corp. in the registry?
The most recently registered devices listed for Ciba Corning Diagnostics Corp. include CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY, GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED, ACS FRT4 IMMUNOASSAY and CIBA CORNING CERTAIN LYTE.