Ciba Corning Diagnostics Corp.

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.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.