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Amico Lab, Inc.

United StatesFDA applicant, unverified

Devices
32

What Amico Lab, Inc. makes

Amico Lab, Inc. manufactures a range of in vitro diagnostic test kits and reagents, including immunofluorescent antibodies and antisera for human immunoglobulins (IgA, IgG, kappa, lambda, and gobulin), as well as kits for detecting pathogens such as Toxoplasma gondii, cytomegalovirus, herpes simplex virus types 1 and 2, and Schistosoma species.

These products are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) database. The company is based in the United States.

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

Catalogue32

Newest first, rows 1-32 of 32

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  • Ritc-Anti Human Iga, Igg, Kappa, Lambda Ref K823121

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

  • Anti-Toxoplasma Gondii Kit Ref K842664

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

  • Fitc Antisera To Human C3 Ref K822679

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

  • Fitc Antisera To Human Igg Ref K822676

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

  • Antiserum To Human Gobulin Ref K822671

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

  • Anti-Cytomegalovirus Kit Ref K842661

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

  • Antiserum To Human Iga Ref K822668

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

  • Amizyme-Andna Test Kit Ref K842533

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

  • Amizyme-Cmv Kit Ref K842529

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

  • Amizyme-Hsv Types 1 & 2 Test Kits Ref K842531

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

  • Amizyme-Toxoplasma Gondii Kit Ref K842528

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

  • Amizyme-Schistosoma Spp. Test Kit Ref K842527

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

  • Amizyme-Ebv Test Kit Ref K842530

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

  • Amizyme-C Trachomatis Test Kit Ref K842525

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

  • Anti-Herpes Simplex Virus Type 1 Or 2 Ref K842663

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

  • Antiserum To Human Kappa Ref K822666

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

  • Anti-Nuclear Antibody Test Kit (Ana) Ref K822681

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

  • Anti-Chlamydia Trachomatis Kit Ref K842658

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

  • Antiserum To Human Lambda Ref K822667

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

  • Antiserum To Human Igm Ref K822670

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

  • Fitc Antisera To Human Lambda Ref K822674

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

  • Amizyme-Ana Test Kit Ref K842532

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

  • Fitc Antisera To Human Igm Ref K822677

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

  • Antiserum To Human Igg Ref K822669

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

  • Amizyme-Leishmania Spp. Test Kit Ref K842526

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

  • Anti-Schistosoma Species Kit Ref K842660

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

  • Anti-Epstein-Barr Virus Kit Ref K842662

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

  • Anti-Native (Double Standard) Dna Test K Ref K822682

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

  • Fitc Antisera To Human Iga Ref K822675

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

  • Fitc Antisera To Human Gobulin Ref K822678

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

  • Wheelchair Mechanical Ref K840024

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

  • Fitc Antisera To Human Kappa Ref K822673

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

Rows 1-32 of 32

Frequently asked questions

How many devices does Amico Lab, Inc. have in the registry?

The registry currently lists 32 devices for Amico Lab, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Amico Lab, Inc.'s devices?

Among its 32 most recently registered devices, Amico Lab, Inc. has devices listed in FDA 510(k) (32 devices).

What risk classes do Amico Lab, Inc.'s devices fall under?

Among its 32 most recently registered devices, the classes recorded for Amico Lab, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Amico Lab, Inc. in the registry?

The most recently registered devices listed for Amico Lab, Inc. include RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA, ANTI-TOXOPLASMA GONDII KIT, FITC ANTISERA TO HUMAN C3 and FITC ANTISERA TO HUMAN IGG.

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