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Ncs Diagnostics, Inc.

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Devices
15

What Ncs Diagnostics, Inc. makes

Ncs Diagnostics, Inc. manufactures diagnostic tests for infectious disease detection, including serological assays like the VDRL carbon antigen test for syphilis screening and the ASO slide test for streptococcal infections. The company also produces culture transport systems, such as KULTSURE variants for gonorrhea and other bacterial cultures, as well as Strepslide for rapid streptococcal antigen detection. Serum transport vials and latex agglutination tests, including the NCS RA latex test, are also part of the portfolio.

The portfolio includes Class I and Class II devices, with regulatory authorisation through the FDA’s 510(k) pathway. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The company operates from the United States.

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

Catalogue15

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  • Vdrl Carbon Antigen Test S900500, S900250 & S90010 Ref K851504

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

  • Aso Slide Test Ref K881209

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

  • Kultsure Starswab(M240), Modification Ref K943499

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

  • Kultsure (Catalogue No. M250) Ref K860658

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

  • Kultsure (Catalogue No. M240) Ref K860657

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

  • Kultsure Ref K870231

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

  • Strepslide Ref K882811

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

  • Kultsure (Catalogue No. M200) Ref K860655

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

  • Kultsure Ref K871404

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

  • Ncs Ra Latex Test Ref K841146

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

  • Serum Transport Vials, T25/Sc, TZ10/Sc Ref K851506

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

  • Kultsure (Culture Transport) Ref K860178

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

  • Kultsure (Catalogue No. M210) Ref K860656

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

  • Kultsure Starswab (M210), Modification Ref K943498

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

  • Staphslide Ref K874019

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

Rows 1-15 of 15

Frequently asked questions

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

The registry currently lists 15 devices for Ncs Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.

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

Among its 15 most recently registered devices, Ncs Diagnostics, Inc. has devices listed in FDA 510(k) (15 devices).

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

Among its 15 most recently registered devices, the classes recorded for Ncs 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 Ncs Diagnostics, Inc. in the registry?

The most recently registered devices listed for Ncs Diagnostics, Inc. include VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010, ASO SLIDE TEST, KULTSURE STARSWAB(M240), MODIFICATION and KULTSURE (CATALOGUE NO. M250).

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