Skip to content

Mercia Diagnostics, Ltd.

United KingdomFDA applicant, unverified

Devices
17

What Mercia Diagnostics, Ltd. makes

Mercia Diagnostics, Ltd. makes diagnostic devices including enzyme immunosassays such as CAPTIA(R) TOXO-M and CAPTIA(R) CMV-G, as well as other tests like ROTASCREEN and TRICHOMATE(R) SUPER for detecting various diseases and conditions.

The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA 510k registry, with the company based in the US.

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

Catalogue17

Newest first, rows 1-17 of 17

Search and filter all 17 devices
Skip device list

  • Captia(R) Rubella-G Ref K883924

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

  • Captia(R) Syphilis-G Ref K881425

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

  • Modified Captia(R) Syphilis-M Ref K900654

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

  • Captia(R) Toxo-M: An Enzyme Immunoassay Ref K871746

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

  • Rotascreen Ref K872568

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

  • Captia Toxo-G Ref K880918

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

  • Captia(R) Syphilis-M Ref K871548

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

  • Trichomate(R) Super Ref K875138

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

  • Rotascreen Eia Ref K873740

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

  • Captia(R) Cmv-G Ref K896194

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

  • Modified Captia(R) Toxo-M Ref K900655

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

  • Captia(R) Cmv-M Ref K896295

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

  • Candidate(R) Super Ref K863499

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

  • Captia Cmv-Ta Ref K915479

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

  • Captia(R) Rubella-M Ref K885300

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

  • Super Duo Ref K892802

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

  • Captia(R) Syphilis M, Modification Ref K904524

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

Rows 1-17 of 17

Frequently asked questions

How many devices does Mercia Diagnostics, Ltd. have in the registry?

The registry currently lists 17 devices for Mercia Diagnostics, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Mercia Diagnostics, Ltd.'s devices?

Among its 17 most recently registered devices, Mercia Diagnostics, Ltd. has devices listed in FDA 510(k) (17 devices).

What risk classes do Mercia Diagnostics, Ltd.'s devices fall under?

Among its 17 most recently registered devices, the classes recorded for Mercia Diagnostics, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Mercia Diagnostics, Ltd. in the registry?

The most recently registered devices listed for Mercia Diagnostics, Ltd. include CAPTIA(R) RUBELLA-G, CAPTIA(R) SYPHILIS-G, MODIFIED CAPTIA(R) SYPHILIS-M and CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY.

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