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Marion Laboratories, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
38

What Marion Laboratories, Inc. makes

Marion Laboratories, Inc. manufactures diagnostic and environmental testing devices, including aerobic culture chambers, sealed droppers for medical solutions, and rapid screening tests for cannabinoids and bacteriuria. Their portfolio also includes environmental monitoring products like the ENVINET™ chamber and ENVISAN paste, as well as medical adhesives, culture identification kits, and disposable bacteriology tools.

The company’s devices are regulated under FDA Class I, Class II, and Unclassified (U) categories, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Marion Laboratories, Inc. have in the registry?

The registry currently lists 38 devices for Marion Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Marion Laboratories, Inc.'s devices?

Among its 38 most recently registered devices, Marion Laboratories, Inc. has devices listed in FDA 510(k) (38 devices).

What risk classes do Marion Laboratories, Inc.'s devices fall under?

Among its 38 most recently registered devices, the classes recorded for Marion Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Marion Laboratories, Inc. in the registry?

The most recently registered devices listed for Marion Laboratories, Inc. include CHAMBER, AEROBIC, DROPPER, CEPTI-SEAL LAVTOPHENOL, DROPPER, SOLUTION TRICHROME, CEPTI-SEAL and TOXI-LAB CANNABINOID THC SCREEN.

Generated automatically from registry data and not verified by a human reviewer.