Chiron Diagnostics Corp.
United StatesFDA applicant, unverified
- Devices
- 20
What Chiron Diagnostics Corp. makes
Chiron Diagnostics Corp. manufactures automated chemiluminescence immunoassay systems and related diagnostic reagents, including the ACS:CENTAUR AFP, ACS:CENTAUR CEA, and ACS:180TU P for measuring biomarkers like alpha-fetoprotein, carcinoembryonic antigen, and tobramycin levels. Their portfolio also covers specialized urine tests and assays for substances such as folate, ferritin, free T3 (FT3), and carbamazepine. The company produces both standalone analyzers and reagent kits designed for laboratory use.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II medical devices. These systems are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 20 devicesFrequently asked questions
How many devices does Chiron Diagnostics Corp. have in the registry?
The registry currently lists 20 devices for Chiron Diagnostics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chiron Diagnostics Corp.'s devices?
Among its 20 most recently registered devices, Chiron Diagnostics Corp. has devices listed in FDA 510(k) (20 devices).
What risk classes do Chiron Diagnostics Corp.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Chiron 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 Chiron Diagnostics Corp. in the registry?
The most recently registered devices listed for Chiron Diagnostics Corp. include ACS:CENTAUR AFP, CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER, CHIRON DIAGNOSTICS ACS:180TU P and SPECIALITY URINE 1, 2.