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Wellcome Diagnostics

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Devices
28

What Wellcome Diagnostics makes

Wellcome Diagnostics makes diagnostic kits and tests, including those for detecting influenza, bacterial antigens, strep, and other infectious diseases. Their products include the WELLCOGEN H. INFLUENZAL ZL21, WELLCOGEN BACTERIAL ANTIGEN KIT, and STREPTEX DIRECT A ZL14, among others. These devices are used to diagnose various conditions, such as meningitis and rotavirus. The company's portfolio also includes tests for detecting specific antibodies and antigens, like the MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51.

The company's devices are classified as Class I and Class II, and are listed in the FDA 510(k) registry. Wellcome Diagnostics is based in the US.

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

Catalogue28

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  • Streptex Acid Extraction Kit Ref K910797

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

  • Wellcogen H. Influenzal ZL21 Ref K833077

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

  • Wellcogen Bacterial Antigen Kit Ref K854852

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

  • Fibri-Prest Automate HA34 Ref K840211 Open recall

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

  • Streptex Direct A ZL14 Ref K842827

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

  • Diacrom * Atiii Ref K832592

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

  • Diacrom * Factor X Kit HA31 Ref K832372

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

  • Streptex ZL01 Ref K842828

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

  • Meningococcus Group B Monoclonal Antibody Zm-51 Ref K844762

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

  • The Wellcome Rotavirus Latex Test ZL40 Ref K861634

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

  • Wellcolex Colour Salmonella Test Zl 50 Ref K890146

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

  • Willcogen Meningitidis Kit ZL25 Ref K851691

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

  • Wellcozyme Hsv WZO2 Ref K875311

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

  • Dac-Cel Diagnatal Rd 50 Ref K830203

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

  • Wellcolex Colour Shigella Test ZC51 Ref K895461

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

  • Dac-Cel Pth Kit RD51 Ref K831069

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

  • Wellcogen N. Meningitidis A, C, Y W135 Ref K833063

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

  • Reveal Colour Strep A ZL16 Ref K864206

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

  • D-Dimer Wellcotest (HA10) Ref K915203

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

  • Wellcogen S. Pneumoniae Ref K841376

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

  • Diacrom * Heparin Ref K832373

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

  • Staphaurex ZL30 Ref K851949

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

  • Dac-Cel Diagnatal Hcg Standards RD49 Ref K830204

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

  • Diacrom *plg Ref K832591

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

  • Reptilase-R HA35 Ref K840210

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

  • Dac-Cel Hcg-Mca Kit RD52 Ref K831073

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

  • Wellcogen N. Meningitidis B/E. Coli K1 ZL24 Ref K854851

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

  • Wellcozyme Rotavirus WZ01 Ref K861628

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

Rows 1-28 of 28

Frequently asked questions

How many devices does Wellcome Diagnostics have in the registry?

The registry currently lists 28 devices for Wellcome Diagnostics. Devices recorded under merged duplicate company entries are counted once.

Which registries list Wellcome Diagnostics's devices?

Among its 28 most recently registered devices, Wellcome Diagnostics has devices listed in FDA 510(k) (28 devices).

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

Among its 28 most recently registered devices, the classes recorded for Wellcome Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Wellcome Diagnostics include STREPTEX ACID EXTRACTION KIT, WELLCOGEN H. INFLUENZAL ZL21, WELLCOGEN BACTERIAL ANTIGEN KIT and FIBRI-PREST AUTOMATE HA34.

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