BEUDAMED
    73 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci

    FDA Enforcement
    Class II ·Terminated·Remel Inc·December 25, 2013

    VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.

    FDA Enforcement
    Class II ·Terminated·Remel Inc·July 1, 2015

    Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.

    FDA Enforcement
    Class II ·Terminated·Remel Inc·July 23, 2014

    VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.

    FDA Enforcement
    Class II ·Terminated·Remel Inc·July 1, 2015

    Yeastone Broth, 11ML, 10/BOX YY3462

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·April 22, 2026

    Campy CVA Medium 100/PK, R01272

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·March 4, 2026

    1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·December 3, 2025

    Strep Selective II Agar, Product Number R01859

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·August 6, 2025

    Blood/MacConkey Biplate 100/PK, Product Number R02049

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·August 6, 2025

    Blood Agar,5% Sheep Blood 100/PK, Product Number R01202

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·August 6, 2025

    Blood/EMB, Levine 100/PK, Product Number R02041

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·August 6, 2025

    remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·February 26, 2025

    remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·February 26, 2025

    remel BactiDrop Acridine Orange, REF 21502, 50 per package.

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·November 6, 2024

    remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·September 20, 2023

    Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.

    FDA Enforcement
    Class II ·Terminated·Remel Inc·February 20, 2013

    Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·January 29, 2014

    Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.

    FDA Enforcement
    Class II ·Terminated·Remel Inc·March 5, 2014

    Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in- vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes

    FDA Enforcement
    Class II ·Terminated·Remel Inc·January 29, 2014

    Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.

    FDA Enforcement
    Class II ·Terminated·Remel Inc·November 19, 2014