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Irvine Diagnostic Services

Country not established

Devices
10

What Irvine Diagnostic Services makes

Irvine Diagnostic Services manufactures biochemical reagents and test strips for microbiological identification, including zinc dust suspension, oxidase test strips, and Voges-Proskauer reagents. Their portfolio also includes specific substrates like L-alanine-4-nitroanilide and indole reagent, as well as hippurate and ONPG test disks for bacterial analysis.

All products fall under Class I medical devices and are listed via FDA 510(k) clearance. The company operates from the United States.

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

Catalogue10

Newest first, rows 1-10 of 10

  • Zinc Dust Suspension Ref K842299

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

  • L-Alanine-4-Nitroanilide Ref K842072

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

  • Voges-Proskauer Reagent B Ref K842867

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

  • Hippurate Test Reagent Ref K842871

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

  • Decarboxylase Test Reagent Ref K842869

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

  • Voges-Proskauer Reagent A Ref K842870

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

  • Oxidase Test Strips-Oxidasesure Ref K842298

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

  • Indole Reagent Ref K842872

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

  • Onpg Disks Ref K842300

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

  • Hippurate Test Disks Ref K842868

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

Frequently asked questions

How many devices does Irvine Diagnostic Services have in the registry?

The registry currently lists 10 devices for Irvine Diagnostic Services. Devices recorded under merged duplicate company entries are counted once.

Which registries list Irvine Diagnostic Services's devices?

Among its 10 most recently registered devices, Irvine Diagnostic Services has devices listed in FDA 510(k) (10 devices).

What risk classes do Irvine Diagnostic Services's devices fall under?

Among its 10 most recently registered devices, the classes recorded for Irvine Diagnostic Services's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Irvine Diagnostic Services in the registry?

The most recently registered devices listed for Irvine Diagnostic Services include ZINC DUST SUSPENSION, L-ALANINE-4-NITROANILIDE, VOGES-PROSKAUER REAGENT B and HIPPURATE TEST REAGENT.

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