BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R2450530 Xpect Giardia/Crypto Control

    Reg #: 1924669 · FEI: 1924669 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    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
    K031834

    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
    Cryptosporidium Spp. MHJ
    Giardia Spp. MHI

    Proprietary Names

    R2450530 Xpect Giardia/Crypto Control R2450520 Xpect Giardia/Crypto Xpect Giardia/Crypto Control Xpect Giardia/Crypto Kit

    Establishment Types

    Manufacture Medical Device