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Genus Diagnostics

Country not established

Devices
9

What Genus Diagnostics makes

Genus Diagnostics produces cell cultures and viral detection reagents, including RK, WI-38, MCCoy, MRC-5, RMK, HEK, VERO, and HEP-2 cell lines, as well as the HSV IDR diagnostic test. These products are used in virology, cell biology research, and infectious disease testing.

The company’s portfolio includes Class I and Class II devices, with some products authorised via the FDA’s 510(k) pathway. These products are listed under US regulatory frameworks and are based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

  • Rk Gencells Ref K851563

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

  • Wi-38 Gencells Ref K851561

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

  • Mccoy Gencells Ref K852204

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

  • Hsv Idr Ref K854974

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

  • Mrc-5 Gencells Ref K851562

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

  • Rmk Gencells Culture System Ref K852205

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

  • Hek Gencells Ref K851928

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

  • Vero Gencells Ref K851927

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

  • Hep-2 Gencells Ref K852206

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

Frequently asked questions

How many devices does Genus Diagnostics have in the registry?

The registry currently lists 9 devices for Genus Diagnostics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Genus Diagnostics's devices?

Among its 9 most recently registered devices, Genus Diagnostics has devices listed in FDA 510(k) (9 devices).

What risk classes do Genus Diagnostics's devices fall under?

Among its 9 most recently registered devices, the classes recorded for Genus Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Genus Diagnostics in the registry?

The most recently registered devices listed for Genus Diagnostics include RK GENCELLS, WI-38 GENCELLS, MCCOY GENCELLS and HSV IDR.

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