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Gen-Probe Prodesse, Inc.

United StatesFDA applicant, unverified

Devices
10

What Gen-Probe Prodesse, Inc. makes

Gen-Probe Prodesse, Inc. manufactures molecular diagnostic assays for respiratory and gastrointestinal pathogens, including tests for influenza, adenovirus, human metapneumovirus (HMPV), and gastrointestinal infections. Their portfolio includes rapid nucleic acid amplification assays designed for use in clinical laboratories to detect specific viral and bacterial targets in patient samples.

The company’s assays are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) database and are intended for use in 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

  • Prodesse Profast+ Assay Ref K132237

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

  • Pro Hmpv+ Assay Ref K132200

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

  • Progastro Sscs Assay Ref K123274

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

  • Pro Hmpv+ Assay Ref K123838

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

  • Prodesse Proflu+ Assay Ref K132129

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

  • Profast+ Assay Ref K101855

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

  • Proadeno+ Assay Ref K132159

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

  • Prodesse Proadeno Ref K102952

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

  • Proparaflu+ Assay Ref K132238

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

  • Proflu+ Assay Ref K110968

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

Frequently asked questions

How many devices does Gen-Probe Prodesse, Inc. have in the registry?

The registry currently lists 10 devices for Gen-Probe Prodesse, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gen-Probe Prodesse, Inc.'s devices?

Among its 10 most recently registered devices, Gen-Probe Prodesse, Inc. has devices listed in FDA 510(k) (10 devices).

What risk classes do Gen-Probe Prodesse, Inc.'s devices fall under?

Among its 10 most recently registered devices, the classes recorded for Gen-Probe Prodesse, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Gen-Probe Prodesse, Inc. in the registry?

The most recently registered devices listed for Gen-Probe Prodesse, Inc. include PRODESSE PROFAST+ ASSAY, PRO HMPV+ ASSAY, PROGASTRO SSCS ASSAY and PRODESSE PROFLU+ ASSAY.

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