American Drug Screens, Inc.
Country not established
- Devices
- 1
What American Drug Screens, Inc. makes
American Drug Screens, Inc. manufactures the AWARE Test System, a device designed for drug testing and screening purposes, likely used in clinical or forensic settings to detect the presence of substances in biological samples.
The company’s portfolio is regulated under Class III designation in the United States, requiring Premarket Approval (PMA) through the FDA. The device is listed in the FDA’s PMA registry, adhering to stringent regulatory requirements for high-risk medical devices.
Catalogue
Aware Test System Ref P900042
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does American Drug Screens, Inc. have in the registry?
The registry currently lists 1 device for American Drug Screens, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Drug Screens, Inc.'s devices?
Among its 1 most recently registered device, American Drug Screens, Inc. has devices listed in FDA PMA (1 device).
What risk classes do American Drug Screens, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for American Drug Screens, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from American Drug Screens, Inc. in the registry?
The most recently registered devices listed for American Drug Screens, Inc. include AWARE TEST SYSTEM.