BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Remel Cleveland, A Division of Remel Inc.

    Reg #: 1530126 · FEI: 1000515493 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    47
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    Remel Cleveland, A Division of Remel Inc.
    Registration Number
    1530126
    FEI Number
    1000515493
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1 Thermo Fisher Way
    City
    Oakwood Village
    State
    OH
    ZIP
    44146
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133038

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Susceptibility Test Plate, Antifungal NGZ
    Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems LRG
    Manual Antimicrobial Susceptibility Test Systems JWY
    Reagent/Device, Inoculum Calibration LIE
    Gram Negative Identification Panel LQM
    Panels, Test, Susceptibility, Antimicrobial LTT
    Nephelometer, For Clinical Use JQX
    Gram Positive Identification Panel LQL
    System, Blood Culturing MDB
    Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth JTZ

    Proprietary Names

    HPB1 Sensititre™ Haemophilus and Streptococcus pneumoniae MIC Plate T3470 Sensititre HTM Broth T3462-10 Sensititre Cation Adjusted Mueller- Hinton Broth w/TES V3030 Sensititre™ OptiRead™ Sensititre AIM™ Sensititre GN Panel Nephelometer Sensititre GP Panel MB1561A Microbact Staph 12S MB1588A Microbact Staph Fast Blue Reagent VersaTREK 7110-44 VERSATREK REDOX 2M, EZ DRAW 40ML 7106-44 VERSATREK REDOX 1, 40 ML W/STIR BAR 7103-44 VERSATREK REDOX 2, 80ML 7103-44M VERSATREK REDOX 2M 80ML 7112-42 VERSATREK MYCO GS 7104-44 VERSATREK REDOX 80ML TWIN-PACK 7111-42 VERSATREK MYCO BOTTLES 7102-44 VERSATREK REDOX 1, 80 ML W/STIR BAR 7107-44 VERSATREK REDOX 2, EZ DRAW 40ML 7111-42M VERSATREK MYCO BOTTLES, W/MODIFIED CAP Y52814 VERSATREK 528 W/14 DRAWERS/CTRL MOD Y52818220 VERSATREK 528 W/18 DR/CTRL MOD 220V Y52820 VERSATREK 528 W/20 DRAWERS/CTRL M Y24008 VERSATREK 240 W/8 DRAWERS/CTRL MOD Y24010220 VERSATREK 240 W/10 DR/CTRL MOD 220V Y52822220 VERSATREK 528 W/22 DR/CTRL MOD 220V Y24004220 VERSATREK 240 W/4 DR/CTRL MOD, 220V Y52818 VERSATREK 528 W/18 DRAWERS/CTRL MOD Y52816 VERSATREK 528 W/16 DRAWERS/CTRL MOD Y52822M VERSATREK M 528 W/22 DRAWERS 7114-42 VERSATREK MYCO AS Y24010 VERSATREK 240 W/10 DRAWERS/CTRL MOD Y24008220 VERSATREK 240 W/8 DR/CTRL MOD, 220V Y24006220 VERSATREK 240 W/6 DR/CTRL MOD, 220V Y52822 VERSATREK 528 W/22 DRAWERS/CTRL MOD Y24004 VERSATREK 240 W/4 DRAWERS/CTRL MOD 7150-44 VersaTREK™ CONNECTOR 7113-42 VERSATREK MYCO PVNA Mueller Hinton Broth T3462-05 MUELLER-HINTON BROTH W/TES 5ml 100/BOX T3462 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES CP112-10 Sensititre Cation Adjusted Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood CP11410 Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood T3491 Sensititre Saline- Tween w/ Glass Beads T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC T3441 Sensititre Middlebrook 7H9 Broth w/OADC

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility