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Livonia Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices
16

What Livonia Diagnostics, Inc. makes

Livonia Diagnostics, Inc. manufactures a range of clinical chemistry reagent sets and enzymatic kits for diagnostic testing. Their product portfolio includes assays for albumin, creatinine, sickle cell, total protein, inorganic phosphorus, SGOT, serum iron, cholesterol, glucose oxidase, urea nitrogen, SGPT, and magnesium.

The company is based in the United States and maintains a portfolio of Class I and Class II medical devices. These products are listed in the FDA 510(k) regulatory registry.

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

Catalogue16

Newest first, rows 1-16 of 16

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  • Albumin Reagent Set Ref K843831

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

  • Creatinine Reagent Set Ref K844024

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

  • Sickle Cell Reagent Set Ref K842368

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

  • Total Protein Reagent Set Ref K843701

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

  • Inorganic Phosphorus Reagent Set Ref K844182

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

  • Sgot Reagent Set Ref K844322

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

  • Serum Iron/Vibc Reagent Set Ref K852161

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

  • Enzymatic Cholesterol Kit Ref K843222

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

  • Glucose Oxidase Enzymatic Reagent Set Ref K843528

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

  • Urea Nitrogen Reagent Set Ref K844156

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

  • Sgpt Reagent Set Ref K844283

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

  • Magnesium Reagent Set Ref K843893

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

  • Total Calcium Reagent Set Ref K843895

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

  • Alkaline Phosphatase Reagent Set Ref K844237

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

  • Uric Acid Reagent Set Ref K844075

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

  • Hdl Precipatating Reagent Set Ref K843894

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

Rows 1-16 of 16

Frequently asked questions

How many devices does Livonia Diagnostics, Inc. have in the registry?

The registry currently lists 16 devices for Livonia Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Livonia Diagnostics, Inc.'s devices?

Among its 16 most recently registered devices, Livonia Diagnostics, Inc. has devices listed in FDA 510(k) (16 devices).

What risk classes do Livonia Diagnostics, Inc.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Livonia Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Livonia Diagnostics, Inc. in the registry?

The most recently registered devices listed for Livonia Diagnostics, Inc. include ALBUMIN REAGENT SET, CREATININE REAGENT SET, SICKLE CELL REAGENT SET and TOTAL PROTEIN REAGENT SET.

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