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Armkel, LLC

United StatesFDA applicant, unverified

Devices
68

What Armkel, LLC makes

Armkel, LLC manufactures rapid diagnostic tests for infectious diseases, including a test for *Influenzae Type B* and *Group B Streptococcus*, as well as pregnancy tests under various brand names such as *First Response* and *Answer*. The company also produces condoms with natural and latex materials, including lubricated and spermicidal variants. Additionally, it supplies reference preparations for rheumatoid factor testing and related diagnostic reagents.

The company’s products are regulated under FDA’s Class I and Class II device classifications, with most cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, and the company operates from the United States.

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

Catalogue68

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  • Genesis B-Hcg Ref K823753

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

  • Magnum Plus Latex Condom W/Spermicidal Lubricant Ref K895640

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

  • Natal-Tec Progesterone Ref K811369

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

  • Chlamydia Igg Elisa Test System Ref K962558

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

  • Virogen Rotatest Slide Test Ref K853399

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

  • Bactigen Group B Streptococcus-Cs Test Ref K872114

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

  • Pregnaslide Ref K863198

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

  • Trojan Extra Large Latex Condom Ref K001212

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

  • Anaton Ref K801046

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

  • Virogen Hsv Antibody Test Ref K871426

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

  • Trojan Passion Berry Gel Ref K013433

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

  • Ucg-Beta Stat Ref K802421

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

  • Trojan Mint Tingle Brand Latex Condoms Ref K023405

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

  • Modification Of Mono-Plus(Tm) Ref K883709

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

  • Bactigen-N. Meningitidis Ref K823880

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

  • Answer At-Home Pregnancy Test Kit Ref K802660

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

  • Positive And Negative Hcg Serum Controls Ref K896875

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

  • Bactigen Salmonella-Shigella Test Ref K870813

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

Rows 51-68 of 68

Showing 51-68 of 68