Keystone Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Keystone Diagnostics, Inc. makes
Keystone Diagnostics, Inc. manufactures rapid, over-the-counter drug screening tests, including the KDI QUIK TEST™ Marijuana Screen and its modified versions for detecting marijuana metabolites in urine samples. These devices are designed for point-of-care use to provide preliminary results for substance use screening.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Modification To Kdi Quik Test Marijuana Screen Ref K875219
Regimes: 510(k) Registry: 510(k)Kdi Quik Test(Tm) Marijuana Screen Ref K870197
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Keystone Diagnostics, Inc. have in the registry?
The registry currently lists 2 devices for Keystone Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Keystone Diagnostics, Inc.'s devices?
Among its 2 most recently registered devices, Keystone Diagnostics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Keystone Diagnostics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Keystone Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Keystone Diagnostics, Inc. in the registry?
The most recently registered devices listed for Keystone Diagnostics, Inc. include MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN and KDI QUIK TEST(TM) MARIJUANA SCREEN.