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Burroughs Wellcome Co.

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Devices
17

What Burroughs Wellcome Co. makes

The company produces diagnostic reagents and immunoassay kits for laboratory testing, including cell-based assays (e.g., SAC-CEL, DAC-CEL T4, DAC-CEL HCG), fluorescent antibodies (e.g., Fluorescent Anti-Human C3), and rapid diagnostic tests (e.g., STREP-TEX, CAMMADISK DIGOXIN). It also manufactures vaccines and immunotherapeutic agents (e.g., THYMUNE-M, THYMUNE-T) and serological reagents for detecting antibodies and antigens, such as CRP-WELLCOTEST and WELLCOGEN Group B.

These products are classified under FDA’s Class I and Class II regulatory categories, with most requiring 510(k) clearance. The company’s devices are listed in the FDA’s 510(k) database, and the portfolio operates under US regulatory oversight. No EU or international registries are referenced in the provided data.

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

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  • Sac-Cel Ref K813508

    Class II
    Active 510(k) 510(k) II

  • Thymune-M Ref K780873

    Class II
    Active 510(k) 510(k) II

  • Toxha Test Ref K771560

    Class II
    Active 510(k) 510(k) II

  • Dac-Cel T4 Ref K791231

    Class II
    Active 510(k) 510(k) II

  • Fluorescent Anti. Anti-Human C3 Ref K771583

    Class II
    Active 510(k) 510(k) II

  • Cammadisk Digoxin Ref K770269

    Class II
    Active 510(k) 510(k) II

  • Wellcogen Group B Ref K820069

    Class I
    Active 510(k) 510(k) I

  • Strep-Tex Ref K781607

    Class I
    Active 510(k) 510(k) I

  • Dac-Cel Hcg Ref K810215

    Class II
    Active 510(k) 510(k) II

  • Dac-Cel Diagnatal Ref K810214

    Class II
    Active 510(k) 510(k) II

  • Thymune-T Ref K780874

    Class II
    Active 510(k) 510(k) II

  • Crp-Wellcotest Ref K771139

    Class II
    Active 510(k) 510(k) II

  • Agglutinating Serum W135 Ref K771562

    Class II
    Active 510(k) 510(k) II

  • Dac-Cel Tsh Ref K810213

    Class II
    Active 510(k) 510(k) II

  • Dac-Cel T3 Ref K791232

    Class II
    Active 510(k) 510(k) II

  • Dac-Cel Digoxin Radioimmunoassay Kit Ref K780475

    Class II
    Active 510(k) 510(k) II

  • Dac-Cel T3 Uptake Ref K810212

    Class II
    Active 510(k) 510(k) II

Rows 1-17 of 17

Frequently asked questions

How many devices does Burroughs Wellcome Co. have in the registry?

The registry currently lists 17 devices for Burroughs Wellcome Co.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Burroughs Wellcome Co.'s devices?

Among its 17 most recently registered devices, Burroughs Wellcome Co. has devices listed in FDA 510(k) (17 devices).

What risk classes do Burroughs Wellcome Co.'s devices fall under?

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

What are the newest devices from Burroughs Wellcome Co. in the registry?

The most recently registered devices listed for Burroughs Wellcome Co. include SAC-CEL, THYMUNE-M, TOXHA TEST and DAC-CEL T4.

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