Tosoh Medics, Inc.
United StatesFDA applicant, unverified
- Devices
- 41
What Tosoh Medics, Inc. makes
Tosoh Medics, Inc. manufactures automated immunoassay analyzers and associated test kits, including the AIA-PACK series for hormone, tumor marker, and genetic assays (e.g., CA 125, troponin I, BRCA), as well as calibration verification sets. The company also produces an automated HPLC analyzer for beta-thalassemia testing and a standalone A1C 2.2 Plus analyzer for measuring glycated hemoglobin levels.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with several products listed via the 510(k) pathway. These products are intended for in vitro diagnostic use and are registered with the U.S. Food and Drug Administration. The manufacturer is based in the United States.
Catalogue
Search and filter all 41 devicesFrequently asked questions
How many devices does Tosoh Medics, Inc. have in the registry?
The registry currently lists 41 devices for Tosoh Medics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tosoh Medics, Inc.'s devices?
Among its 41 most recently registered devices, Tosoh Medics, Inc. has devices listed in FDA 510(k) (41 devices).
What risk classes do Tosoh Medics, Inc.'s devices fall under?
Among its 41 most recently registered devices, the classes recorded for Tosoh Medics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tosoh Medics, Inc. in the registry?
The most recently registered devices listed for Tosoh Medics, Inc. include AIA-PACK HGH, AIA-PACK BMG, ST AIA-PACK CA 125 ENZYME IMMUNOASSAY and AIA-PACK PAP CALIBRATION VERIFICATION TEST SET.