BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    N FLC Standard SL

    Reg #: 3014271897 · FEI: 3014271897 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SANQUIN REAGENTS B.V.
    Registration Number
    3014271897
    FEI Number
    3014271897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plesmanlaan125
    City
    Amsterdam Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K171742

    Owner / Operator

    Firm Name
    Sanquin Reagents B.V.
    Operator Number
    10056688
    Address
    Plesmanlaan125
    City
    Amsterdam
    State
    Noord-Holland
    Postal Code
    1066CX
    Country
    NL
    Correspondent
    Marieke Keller

    Products

    Device Name Product Code
    Lambda, Antigen, Antiserum, Control DEH
    Kappa, Antigen, Antiserum, Control DFH

    Proprietary Names

    N FLC Standard SL N FLC Control SL1 N FLC Control SL2 N Latex FLC kappa N Latex FLC lambda N FLC Supplementary Reagent

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)