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Neogenex

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Devices
20

What Neogenex makes

Neogenex produces primary and continuous cell cultures derived from human, monkey, rabbit, and other animal sources, including primary monkey kidney, MRC-5, A549, MDCK, and VERO cells. The company also manufactures rapid diagnostic tests for influenza B antigen and cytomegalovirus (CMV) early antigen detection.

These products are regulated under FDA Class I and Class II device classifications, with some requiring 510(k) clearance. The cell cultures and diagnostic tests are listed in the FDA’s 510(k) registry, and the company operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue20

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  • Chlamydia Trachomatis Antigen Test Ref K941714

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

  • Rsv Antigen Test Ref K942173

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

  • Influenza A Antigen Test Ref K942172

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

  • Influenza B Anitgen Test Ref K942174

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

  • Primary Monkey Kidney Cell Culture Ref K943884

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

  • Mccoy Culture Cell Ref K933924

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

  • Mrc-5 Culture Cell Ref K933925

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

  • Primary Rabbit Kidney Cell Culture Ref K943885

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

  • Human Newborn Foreskin Cell Culture Ref K943887

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

  • A549 Culture Cell Ref K933923

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

  • Mdck Cell Culture Ref K943888

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

  • WI38 Cell Culture Ref K943890

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

  • Cmv Early Antigen Test Ref K942171

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

  • LLCMK2 Culture Cells Ref K933926

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

  • Vero Cell Culture Ref K943889

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

  • Bgm Cell Culture Ref K943886

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

  • Mink Lung Cell Culture Ref K965047

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

  • H292 Cell Culture Ref K960909

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

  • Hep-2 Culture Cell Ref K933927

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

  • Rd Culture Cell Ref K943891

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

Rows 1-20 of 20

Frequently asked questions

How many devices does Neogenex have in the registry?

The registry currently lists 20 devices for Neogenex. Devices recorded under merged duplicate company entries are counted once.

Which registries list Neogenex's devices?

Among its 20 most recently registered devices, Neogenex has devices listed in FDA 510(k) (20 devices).

What risk classes do Neogenex's devices fall under?

Among its 20 most recently registered devices, the classes recorded for Neogenex's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Neogenex in the registry?

The most recently registered devices listed for Neogenex include CHLAMYDIA TRACHOMATIS ANTIGEN TEST, RSV ANTIGEN TEST, INFLUENZA A ANTIGEN TEST and INFLUENZA B ANITGEN TEST.

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