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Monoclonal Antibodies, Inc.

United StatesFDA applicant, unverified

Devices
14

What Monoclonal Antibodies, Inc. makes

Monoclonal Antibodies, Inc. manufactures diagnostic test kits and assays for detecting human chorionic gonadotropin (HCG), luteinizing hormone (LH), and herpes simplex virus (HSV) in urine samples. These include products such as the UCG Assay, Ovustick Urine HLH Kit, Plus Urine HCG Assay, B-Clone HCG Assay, Ovustick Self-Test, Pregnastick Urine HCG Kit, Ovquick Self-Test (Ovuquick; Ramp LH Assay), Ramp Progesturine PDG Assay--48 Test Kit, Ramp Urine HCG Assay, HCG Control Kit, and Ovustick Self-Test -Modification.

The company's devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Monoclonal Antibodies, Inc. is based in the United States.

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

Catalogue14

Newest first, rows 1-14 of 14

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  • Model Ucg Assay Ref K822520

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

  • Ovu Stick Urine Hlh Kit Ref K840412

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

  • Plus Urine Hcg Assay Ref K840738

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

  • B-Clone Hcg Assay Ref K831155

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

  • Ovustick Self-Test Ref K843284

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

  • Ramp Herpes Simplex Virus (Hsv) (Cct) Ref K874863

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

  • Pregnastick Urine Hcg Kit Ref K833504

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

  • Ovuquick Self-Test (Ovuquick; Ramp Lh Assay) Ref K871726

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

  • Ramp Progesturine Pdg Assay--48 Test Kit Ref K860924

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

  • Ramp Urine Hcg Assay Ref K854611

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

  • Hcg Control Kit Ref K863744

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

  • Ovu Stick Self-Test -Modification Ref K850480

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

  • Model Serum Hcg Assay Ref K850730

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

  • Serum Hcg Assay Ref K832562

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

Rows 1-14 of 14

Frequently asked questions

How many devices does Monoclonal Antibodies, Inc. have in the registry?

The registry currently lists 14 devices for Monoclonal Antibodies, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Monoclonal Antibodies, Inc.'s devices?

Among its 14 most recently registered devices, Monoclonal Antibodies, Inc. has devices listed in FDA 510(k) (14 devices).

What risk classes do Monoclonal Antibodies, Inc.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Monoclonal Antibodies, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Monoclonal Antibodies, Inc. in the registry?

The most recently registered devices listed for Monoclonal Antibodies, Inc. include MODEL UCG ASSAY, OVU STICK URINE HLH KIT, PLUS URINE HCG ASSAY and B-CLONE HCG ASSAY.

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