Environmental Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Environmental Diagnostics, Inc. makes
Environmental Diagnostics, Inc. manufactures rapid drug and substance screening devices, including single-use tests for barbiturates, opiates, hCG, cannabinoids, amphetamines, and combined cannabinoid/cocaine detection. These products are designed for point-of-care or field use to provide qualitative results within minutes.
The company’s portfolio consists of Class II medical devices, each authorised via the FDA’s 510(k) clearance process. These devices are listed under the FDA’s regulatory framework and are intended for use in the United States.
Catalogue
Ez-Screen:barbiturates Ref K905057
Regimes: 510(k) Registry: 510(k)Ez-Screen:opiates Ref K900203
Regimes: 510(k) Registry: 510(k)Ez-Screen:hcg Ref K902681
Regimes: 510(k) Registry: 510(k)Ez-Screen: Cannabinoid Ref K862916
Regimes: 510(k) Registry: 510(k)Ez-Screen: Amphetamines Ref K905700
Regimes: 510(k) Registry: 510(k)Ez-Screen Cannabinoid/Cocaine Ref K883105
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Environmental Diagnostics, Inc. have in the registry?
The registry currently lists 6 devices for Environmental Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Environmental Diagnostics, Inc.'s devices?
Among its 6 most recently registered devices, Environmental Diagnostics, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Environmental Diagnostics, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Environmental Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Environmental Diagnostics, Inc. in the registry?
The most recently registered devices listed for Environmental Diagnostics, Inc. include EZ-SCREEN:BARBITURATES, EZ-SCREEN:OPIATES, EZ-SCREEN:HCG and EZ-SCREEN: CANNABINOID.