Marion Health & Safety, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Marion Health & Safety, Inc. makes
Marion Health & Safety, Inc. manufactures diagnostic swabs, including the STREP CULTURETTE for strep throat testing and the VIRAL CULTURETTE with Hank’s Balanced Salt Solution for viral sample collection.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Strep Culturette Ref K792201
Regimes: 510(k) Registry: 510(k)Viral Culturette Hank's Bal. Salt Sol. Ref K800832
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Marion Health & Safety, Inc. have in the registry?
The registry currently lists 2 devices for Marion Health & Safety, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Marion Health & Safety, Inc.'s devices?
Among its 2 most recently registered devices, Marion Health & Safety, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Marion Health & Safety, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Marion Health & Safety, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Marion Health & Safety, Inc. in the registry?
The most recently registered devices listed for Marion Health & Safety, Inc. include STREP CULTURETTE and VIRAL CULTURETTE HANK'S BAL. SALT SOL..