Innotron of Oregon, Inc.
United StatesFDA applicant, unverified
- Devices
- 28
What Innotron of Oregon, Inc. makes
Innotron of Oregon, Inc. manufactures calibrator sets, reagent kits, and fluorimeters for clinical chemistry, including products for measuring phenytoin, vancomycin, gentamicin, phenobarbital, and quinidine levels. Their offerings include manual and automated fluorescence polarization immunoassay (FPIA) reagents, colorimeters, and specialized calibrators for drug monitoring in hospital and laboratory settings.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with products listed via the 510(k) clearance pathway. These devices are intended for in vitro diagnostic use and are registered with the U.S. Food and Drug Administration.
Catalogue
Search and filter all 28 devicesFrequently asked questions
How many devices does Innotron of Oregon, Inc. have in the registry?
The registry currently lists 28 devices for Innotron of Oregon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innotron of Oregon, Inc.'s devices?
Among its 28 most recently registered devices, Innotron of Oregon, Inc. has devices listed in FDA 510(k) (28 devices).
What risk classes do Innotron of Oregon, Inc.'s devices fall under?
Among its 28 most recently registered devices, the classes recorded for Innotron of Oregon, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Innotron of Oregon, Inc. in the registry?
The most recently registered devices listed for Innotron of Oregon, Inc. include INNOFLUOR PHENYTOIN CALIBRATOR SET, COLORIMETERS SERIES ONE 12, INNOFLUOR VANCOMYCIN CALIBRATOR SET and HYDRAGAMMA 16.