American Type Culture Collection
Country not established
- Devices
- 1
What American Type Culture Collection makes
American Type Culture Collection provides microbiological reference materials, including the SUSCEPTROL product line, which are used for testing antimicrobial susceptibility in clinical laboratories. These materials help standardize and validate bacterial resistance profiling to ensure accurate diagnostic results.
The company’s products fall under FDA Class I devices and are listed via the 510(k) pathway. The portfolio is regulated under US medical device laws, and the organization operates from the United States.
Catalogue
Susceptrol Ref K820064
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Type Culture Collection have in the registry?
The registry currently lists 1 device for American Type Culture Collection. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Type Culture Collection's devices?
Among its 1 most recently registered device, American Type Culture Collection has devices listed in FDA 510(k) (1 device).
What risk classes do American Type Culture Collection's devices fall under?
Among its 1 most recently registered device, the classes recorded for American Type Culture Collection's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from American Type Culture Collection in the registry?
The most recently registered devices listed for American Type Culture Collection include SUSCEPTROL.