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Columbia Bioscience, Inc.

United StatesFDA applicant, unverified

Devices
13

What Columbia Bioscience, Inc. makes

Columbia Bioscience, Inc. manufactures a range of ELISA test systems for the detection of antibodies, including those for anti-TPO, anti-PR3, anti-MPO, anti-TG, Borrelia burgdorferi, VCA, EBNA-1, Mumps, and H. pylori. The company also produces laboratory instrumentation, specifically the Anthos Phacts version microplate reader and the CBI 7520 reader.

The company is based in the United States and maintains a portfolio of devices categorized as Class I and Class II. These products are listed within the FDA 510(k) regulatory registry.

AI-generated from registry data, 29 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Columbia Bioscience, Inc. have in the registry?

The registry currently lists 13 devices for Columbia Bioscience, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Columbia Bioscience, Inc.'s devices?

Among its 13 most recently registered devices, Columbia Bioscience, Inc. has devices listed in FDA 510(k) (13 devices).

What risk classes do Columbia Bioscience, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Columbia Bioscience, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Columbia Bioscience, Inc. in the registry?

The most recently registered devices listed for Columbia Bioscience, Inc. include IS ANTI-TPO IGG ELISA TEST SYSTEM, IS BORRELIA BURGDORFERI IGM TEST SYSTEM, ANTHOS PHACTS VERSION MICROPLATE READER and IS-ANTI-PR3 IGG ELISA TEST SYSTEM.

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