Baxter Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 72
What Baxter Diagnostics, Inc. makes
Baxter Diagnostics, Inc. manufactures diagnostic controls, immunoassay cartridges, dried microbiology panels, and reagent kits for laboratory testing. Products include tri-level controls for myoglobin and urine chemistry, EIA assays for herpes simplex virus 2 and rubella IgM, and immunofluorescence (IFA) test kits for parainfluenza and respiratory syncytial virus (RSV) detection. Additional offerings cover Gram-negative bacterial panels and phenytoin reagent strips for clinical monitoring.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These products are intended for in vitro diagnostic use and are listed in the FDA’s 510(k) registry. Baxter Diagnostics, Inc. is based in the United States.
Catalogue
Search and filter all 72 devicesShowing 1-50 of 72
Frequently asked questions
How many devices does Baxter Diagnostics, Inc. have in the registry?
The registry currently lists 72 devices for Baxter Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Baxter Diagnostics, Inc.'s devices?
Among its 50 most recently registered devices, Baxter Diagnostics, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Baxter Diagnostics, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Baxter Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Baxter Diagnostics, Inc. in the registry?
The most recently registered devices listed for Baxter Diagnostics, Inc. include DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL, BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE, BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA and DRIED GRAM-NEGATIVE MIC/COMBO PANELS.