BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Microtest M4RT Transport

    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
    K921472

    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

    Microtest M4RT Transport R12505 M4RT tube R12567 M4RT Universal Flock Swab Kit PK/100 R12592 M4RT kit w/o beads w/ flocked swab R12591 M4RT w/o beads 72/pk R12566 M4RT MicroTip Flock Swab Kit PK/100 R12552 M4RT kit R12506 M4RT tube R12701 M4RT w/o beads R12900 M4RT kit w/ NP swab & OP swab R12565 M4RT Kit w/Traditional-Tipped Flocked Swab R12599 M4RT kit R12587 M4RT Tube PK/72 R12593 M4RT kit w/o beads R12950 M4RT Tube without beads (50 ct) R12578 M4RT Universal Kit R12588 M4RT KIT w/ FLOCKED SWAB PK/100 R12700 M4RT w/o beads R12705 M4RT kit w/ NP swab R12901 M4RT kit w/ 100 NP R12952 M4RT w/o beads kit w/ nasal swab and bag R12576 M4RT Universal Plus Swab Kit PK/100

    Establishment Types

    Manufacture Medical Device