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Val Tech Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices
11

What Val Tech Diagnostics, Inc. makes

Val Tech Diagnostics, Inc. manufactures diagnostic slides and test kits for microbiological and immunological analysis, including control slides for Legionella, fungal, Gram-negative bacteria, acid-fast bacteria, parasitic organisms, and herpes virus. Their products also include substrates for antinuclear antibody (ANA) testing, such as dual substrate ANA and histone-reactive ANA systems, alongside a dedicated ANA test kit and a rat liver nuclei test system for reference standards.

The company’s portfolio comprises Class I and Class II devices, with several products authorised via the FDA’s 510(k) pathway. These diagnostic tools are intended for laboratory use in identifying and confirming microbial and viral infections, as well as autoimmune marker detection. The company is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • Histo-Check Legionella Control Slides Ref K883567

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

  • Dual Substrate Ana Ref K871395

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

  • Histo-Check Fungal Control Slides Ref K883570

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

  • Histo-Check Gram Negative Slides Ref K883569

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

  • Histo-Check Acid Fast Slides Ref K883568

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

  • Herpes Virus Control Slides Ref K883684

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

  • Histo-Check Slides Ref K883208

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

  • Histone Reactive Ana Ref K883232

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

  • Ana Test Kit Ref K864668

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

  • Rat Liver Nuclei Test System Ref K870732

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

  • Histo-Check Parasitic Control Slides Ref K883571

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

Rows 1-11 of 11

Frequently asked questions

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

The registry currently lists 11 devices for Val Tech Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Val Tech Diagnostics, Inc.'s devices?

Among its 11 most recently registered devices, Val Tech Diagnostics, Inc. has devices listed in FDA 510(k) (11 devices).

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

Among its 11 most recently registered devices, the classes recorded for Val Tech 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 Val Tech Diagnostics, Inc. in the registry?

The most recently registered devices listed for Val Tech Diagnostics, Inc. include HISTO-CHECK LEGIONELLA CONTROL SLIDES, DUAL SUBSTRATE ANA, HISTO-CHECK FUNGAL CONTROL SLIDES and HISTO-CHECK GRAM NEGATIVE SLIDES.

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