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Wampole Laboratories

Country not established

Devices
12

What Wampole Laboratories makes

Wampole Laboratories manufactures a range of in vitro diagnostic (IVD) tests, including immunological assays for detecting antibodies such as rubella, Borrelia burgdorferi (IgG/IgM), and cytomegalovirus (CMV). Their portfolio also includes rapid diagnostic tests like the MONO-PLUS™ for mononucleosis detection, a microalbumin test for kidney function assessment, and pregnancy testing systems such as the ONE-STEP HCG. Additional offerings include fluorescent antibody assays (IFA-ANA) for autoimmune marker detection and enzyme-linked immunosorbent assays (ELISA) for specific infectious disease markers.

The company’s diagnostic devices are classified under FDA categories, with most falling into Class I and Class II regulatory classifications. These products are listed under the FDA’s 510(k) pathway, indicating they meet regulatory requirements for marketing in the United States. The manufacturer operates from the US, adhering to domestic regulatory standards for in vitro diagnostics.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

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  • Indirect Fluorescent (Ifa-Ana) Ref K760681

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

  • Rubella Virus Immunological Test System Ref K911444

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

  • Borrelia Burgdorferi Igg/Igm Elisa Test System Ref K965131

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

  • Mono-Plus(Tm) Ref K883004

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

  • Virogen Cmv Antibody Test Ref K875101

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

  • Beta-Tec Ref K781794

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

  • Biocept-G Ref K760336

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

  • Rf Controls Ref K790986

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

  • One-Step Hcg Ref K882896

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

  • Mat (Tm) Microalbumin Test Ref K875161

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

  • Ucg-Lyphotest Ref K791309

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

  • Borrelia Burgdorferi Igm Elisa Test System Ref K965129

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

Rows 1-12 of 12

Frequently asked questions

How many devices does Wampole Laboratories have in the registry?

The registry currently lists 12 devices for Wampole Laboratories. Devices recorded under merged duplicate company entries are counted once.

Which registries list Wampole Laboratories's devices?

Among its 12 most recently registered devices, Wampole Laboratories has devices listed in FDA 510(k) (12 devices).

What risk classes do Wampole Laboratories's devices fall under?

Among its 12 most recently registered devices, the classes recorded for Wampole Laboratories's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Wampole Laboratories in the registry?

The most recently registered devices listed for Wampole Laboratories include INDIRECT FLUORESCENT (IFA-ANA), RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM, BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM and MONO-PLUS(TM).

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