Windsor Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 19
What Windsor Laboratories, Inc. makes
Windsor Laboratories, Inc. manufactures fluorescence polarization immunoassay (FPIA) kits for measuring drug concentrations in clinical samples, including phenytoin, phenobarbital, tobramycin, amikacin, gentamicin, digoxin, and carbamazepine. The company also produces calibrator kits and assay buffers for these tests, as well as rapid diagnostic kits for detecting *Neisseria* species and beta-lactamase activity in bacterial samples.
The portfolio includes Class I and Class II devices, with several products authorised via the FDA’s 510(k) pathway. These products are listed under U.S. regulatory requirements and are intended for in vitro diagnostic use. The manufacturer is based in the United States.
Catalogue
Search and filter all 19 devicesFrequently asked questions
How many devices does Windsor Laboratories, Inc. have in the registry?
The registry currently lists 19 devices for Windsor Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Windsor Laboratories, Inc.'s devices?
Among its 19 most recently registered devices, Windsor Laboratories, Inc. has devices listed in FDA 510(k) (19 devices).
What risk classes do Windsor Laboratories, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Windsor Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Windsor Laboratories, Inc. in the registry?
The most recently registered devices listed for Windsor Laboratories, Inc. include PHENYTOIN (FPIA) CALIBRATOR KIT, (FPIA) ASSAY BUFFER, PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT and TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU.