Bayer Diagnostics Corp.
United StatesFDA applicant, unverified
- Devices
- 32
What Bayer Diagnostics Corp. makes
Bayer Diagnostics Corp. manufactures diagnostic assays, controls, calibrators, and systems for clinical laboratory testing, including tests for salicylate, ammonia, uric acid, CA 15-3, acetaminophen, prostate specific antigen (PSA), digoxin, and anti-TPO, as well as the ADVIA 120 Hematology System and ACS:180 and ADVIA Centaur immunoassay systems.
The company's products are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) database. Bayer Diagnostics Corp. is based in the US.
Catalogue
Search and filter all 32 devicesFrequently asked questions
How many devices does Bayer Diagnostics Corp. have in the registry?
The registry currently lists 32 devices for Bayer Diagnostics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bayer Diagnostics Corp.'s devices?
Among its 32 most recently registered devices, Bayer Diagnostics Corp. has devices listed in FDA 510(k) (32 devices).
What risk classes do Bayer Diagnostics Corp.'s devices fall under?
Among its 32 most recently registered devices, the classes recorded for Bayer 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 Bayer Diagnostics Corp. in the registry?
The most recently registered devices listed for Bayer Diagnostics Corp. include SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, BAYER SPECIAL CHEMISTRY CONTROLS, AMMONIA ASSAY FOR THE ADVIA 1650 and URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM.