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Quest Intl., Inc.

United StatesFDA applicant, unverified

Devices
25

What Quest Intl., Inc. makes

Quest International, Inc. manufactures immunological test systems for detecting specific antibodies, including anti-cardiolipin and multiple autoantibodies, as well as individual antibody assays such as anti-thyroglobulin, toxoplasma IgG/IgM, cytomegalovirus (CMV) IgM/IgG, rubella IgG, and anti-Smith (anti-SM). The company also produces latex examination gloves and modified versions of certain antibody test systems, such as VCA IgM.

The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with several products listed via the 510(k) pathway. These products are regulated under the U.S. Food and Drug Administration’s medical device authorities and are intended for use in clinical laboratories for diagnostic purposes.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue25

Newest first, rows 1-25 of 25

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  • Anti-Cardiolipin, Multiple Autoantibodies Immunological Test System Ref K003069

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

  • Seraquest Eb Na Igg Ref K991975

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

  • Seraquest Anti-Thyroglobulin Ref K023592

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

  • Latex Examination Gloves Non-Sterile Ref K890356

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

  • Seraquest Toxoplasma Igg Ref K960092

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

  • Seraquest Vzv Igg Ref K972295

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

  • Seraquest Cmv Igm Ref K982485 Open recall

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

  • Seraquest Cmv Igg Ref K954191

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

  • Seraquest Rubella Igg Ref K961053

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

  • Seraquest Anti-Sm Ref K980540

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

  • Modification To Seraquest Vca Igm Ref K033780

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

  • Seraquest Toxoplasma Igm Ref K971672

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

  • Seraquest Hsv Igg Ref K963282

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

  • Seraquest Anti-Ssb Ref K980639

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

  • Patient Examination Gloves (Latex) Ref K891736

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

  • Seraquest Anti-Dsdna Ref K980391

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

  • Seraquest Anti-Thyroid Peroxidase (Tpo) Ref K023593

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

  • Seraquest Ebv Ea-D Igg Test Ref K091260

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

  • Seraquest Mumps Igg Ref K980059

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

  • Seraquest Eb Vac Igm Ref K990977

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

  • Seraquest Anti-Ssa Ref K980810

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

  • Modification To Seraquest Eb Vca Igg Ref K033915

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

  • Seraquest Eb Vca Igg Ref K990410

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

  • Seraquest Anti-Sm/Rnp Ref K980811

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

  • Seraquest Rubella Igm Ref K982281

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

Rows 1-25 of 25

Frequently asked questions

How many devices does Quest Intl., Inc. have in the registry?

The registry currently lists 25 devices for Quest Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Quest Intl., Inc.'s devices?

Among its 25 most recently registered devices, Quest Intl., Inc. has devices listed in FDA 510(k) (25 devices).

What risk classes do Quest Intl., Inc.'s devices fall under?

Among its 25 most recently registered devices, the classes recorded for Quest Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Quest Intl., Inc. in the registry?

The most recently registered devices listed for Quest Intl., Inc. include ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM, SERAQUEST EB NA IGG, SERAQUEST ANTI-THYROGLOBULIN and LATEX EXAMINATION GLOVES NON-STERILE.

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