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Remel, L.P.

United StatesFDA applicant, unverified

Devices
10

What Remel, L.P. makes

Remel, L.P. manufactures microbiological culture media, susceptibility testing disks, and diagnostic test kits for identifying bacterial pathogens. Their products include selective and differential agar plates, broth media for bacterial growth, and latex agglutination kits for rapid pathogen detection. They also supply reference controls and antimicrobial resistance testing reagents for clinical laboratories.

The company’s portfolio is regulated under both Class I and Class II medical device classifications in the U.S., with many products authorised through the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer operates from the United States.

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

Catalogue10

Newest first, rows 1-10 of 10

  • Rpr Card Test Kit Ref K955136

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

  • 10B Arginine Broth Ref K961046

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

  • Remel Meropenem 10UG Susceptibility Disk Ref K964421

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

  • Rpr Liquid Controls Ref K955143

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

  • Gc Base W/ 1% Gchi Ref K954986 Open recall

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

  • Mueller Hinton Agar With 2% Naci Ref K960313

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

  • Remel Bile Esculin Azide Agar W/6 Mcg/Ml Vancomycin Ref K972359

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

  • Gentamicin Disk (120mcg) Ref K961818

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

  • Remel Staph Latex Kit Ref K964315

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

  • Streptomycin Disk (300mcg) Ref K961819

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

Frequently asked questions

How many devices does Remel, L.P. have in the registry?

The registry currently lists 10 devices for Remel, L.P.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Remel, L.P.'s devices?

Among its 10 most recently registered devices, Remel, L.P. has devices listed in FDA 510(k) (10 devices).

What risk classes do Remel, L.P.'s devices fall under?

Among its 10 most recently registered devices, the classes recorded for Remel, L.P.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Remel, L.P. in the registry?

The most recently registered devices listed for Remel, L.P. include RPR CARD TEST KIT, 10B ARGININE BROTH, REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK and RPR LIQUID CONTROLS.

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