BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R12560 M6(1.5ml)Traditional FlockSwab Kit

    Reg #: 1924669 · FEI: 1924669 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    REMEL, INC.
    Registration Number
    1924669
    FEI Number
    1924669
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12076 Santa Fe Trail Dr
    City
    LENEXA
    State
    KS
    ZIP
    66215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K910526

    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
    Culture Media, Non-Propagating Transport JSM

    Proprietary Names

    R12560 M6(1.5ml)Traditional FlockSwab Kit R12557 M6Traditional Swab Kit R12503 M4w/o Beads R12500 M4 R12520 M4Glass Dram R12530 M6 R12582 M6 Universal Swab Kit R12561 M6(1.5ml)MicroTip Flock Swab Kit R12570 M4Universal Swab Kit R12571 M4Universal Plus Kit R12559 M6 Universal (Alum) Swab Kit R12521 M4Plastic Dram R12568 M6Traditional FlockSwab Kit R12562 M6(1.5ml)Universal Flock Swab Kit R12502 M4 R12563 M6 Universal Flock Swab Kit R12569 M6 MicroTip Flock Swab Kit R12535 M6 R12550 M4Traditional Swab Kit R12533 M6 Microtest M4 Transport Microtest M6 Transport

    Establishment Types

    Manufacture Medical Device