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Igen, Inc.

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Devices
1

What Igen, Inc. makes

Igen, Inc. makes the ORIGEN ANALYZER, a device used for analyzing biological samples in clinical or laboratory settings.

The ORIGEN ANALYZER is classified as a Class I medical device and is listed in the FDA 510(k) registry; the company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

  • Origen Analyzer Ref K962166

    Active Regimes: 510(k) Registry: 510(k) Class:I

Frequently asked questions

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

The registry currently lists 1 device for Igen, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Igen, Inc.'s devices?

Among its 1 most recently registered device, Igen, Inc. has devices listed in FDA 510(k) (1 device).

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

Among its 1 most recently registered device, the classes recorded for Igen, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Igen, Inc. include ORIGEN ANALYZER.

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