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Innovative Diagnostic Systems, Inc.

United StatesFDA applicant, unverified

Devices
11

What Innovative Diagnostic Systems, Inc. makes

Innovative Diagnostic Systems, Inc. manufactures rapid diagnostic test systems for microbiological identification, including kits for detecting bacterial species (e.g., *Staphylococcus*, enteric pathogens), yeast, and other pathogens. Their portfolio includes systems for identifying *Streptococcus*, *Escherichia coli*, and other clinically relevant organisms, as well as reagents for porphyrin detection. These tests are designed for point-of-care or laboratory use to expedite identification of infectious agents.

The company’s devices are classified as Class I under FDA regulations and are listed via 510(k) clearance. Their products are intended for use in the United States, where regulatory compliance is required for market distribution. No additional international registries or classifications are referenced in the provided data.

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

Catalogue11

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  • Ids Rapid Cb Plus System Ref K962966

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

  • Ids Rapid Str System Ref K833654

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

  • Ida Rapid O2A System Ref K820483

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

  • Rapid Nf System Ref K900517

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

  • Ids Rapid Ana System Ref K882960

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

  • Ids Staphylochrome Test Ref K822144

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

  • Ids Rapid Ss/U System Ref K852871

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

  • Ids Rapid E Plus System Ref K852110

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

  • Ids Porphyrin Reagent Ref K812859

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

  • Modified Ids Rapid Nh System Ref K881501

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

  • Rapid Yeast Plus System Ref K943621

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

Rows 1-11 of 11

Frequently asked questions

How many devices does Innovative Diagnostic Systems, Inc. have in the registry?

The registry currently lists 11 devices for Innovative Diagnostic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Innovative Diagnostic Systems, Inc.'s devices?

Among its 11 most recently registered devices, Innovative Diagnostic Systems, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Innovative Diagnostic Systems, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Innovative Diagnostic Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Innovative Diagnostic Systems, Inc. in the registry?

The most recently registered devices listed for Innovative Diagnostic Systems, Inc. include IDS RAPID CB PLUS SYSTEM, IDS RAPID STR SYSTEM, IDA RAPID O2A SYSTEM and RAPID NF SYSTEM.

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