Cogent Diagnotics, Ltd.
Country not established
- Devices
- 31
What Cogent Diagnotics, Ltd. makes
Cogent Diagnostics, Ltd. manufactures a range of automated immunoassay systems for detecting autoantibodies, including ELISA-based tests for antithyroglobulin, anti-DSDNA, anti-SS-A/RO, anti-cardiolipin, anti-myeloperoxidase (MPO), anti-gladin IgA, anti-Smith (SM), and ENA-4 profile markers. The portfolio also includes tests for anti-dsDNA and anti-PR3 (C-ANCA) antibodies, supporting diagnostic evaluation in autoimmune and rheumatological conditions.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 31 devicesFrequently asked questions
How many devices does Cogent Diagnotics, Ltd. have in the registry?
The registry currently lists 31 devices for Cogent Diagnotics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cogent Diagnotics, Ltd.'s devices?
Among its 31 most recently registered devices, Cogent Diagnotics, Ltd. has devices listed in FDA 510(k) (31 devices).
What risk classes do Cogent Diagnotics, Ltd.'s devices fall under?
Among its 31 most recently registered devices, the classes recorded for Cogent Diagnotics, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cogent Diagnotics, Ltd. in the registry?
The most recently registered devices listed for Cogent Diagnotics, Ltd. include AUTOSTAT ANTITHYROGLOBIN, AUTOSTAT(TM) ANTI-DSNA, AUTOSTAT ANTI-THYROGLOBULIN and AUTOSTAT II ANTI-SS-A/RO ELISA.