American Biomedical Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What American Biomedical Corp. makes
American Biomedical Corp. manufactures Mueller Hinton Agar and Thayer Martin Agar, both used for culturing and identifying bacterial pathogens in clinical microbiology. Mueller Hinton Agar supports antimicrobial susceptibility testing, while Thayer Martin Agar is designed for the isolation of fastidious pathogens like *Neisseria gonorrhoeae* and *Chlamydia trachomatis*. These media are essential for diagnostic laboratories performing routine bacterial identification and antibiotic resistance profiling.
The company’s products are classified as Class II medical devices under FDA regulations and are subject to 510(k) clearance requirements. Both agars are listed in the FDA’s 510(k) database, reflecting their authorised status for clinical use in the United States. The manufacturer operates from the US, adhering to domestic regulatory standards for diagnostic in vitro devices.
Catalogue
Mueller Hinton Agar Ref K833861
Regimes: 510(k) Registry: 510(k)Thayer Martin Agar Ref K833862
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Biomedical Corp. have in the registry?
The registry currently lists 2 devices for American Biomedical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Biomedical Corp.'s devices?
Among its 2 most recently registered devices, American Biomedical Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do American Biomedical Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for American Biomedical Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Biomedical Corp. in the registry?
The most recently registered devices listed for American Biomedical Corp. include MUELLER HINTON AGAR and THAYER MARTIN AGAR.