BEUDAMED
    FDA Registration Active 🇺🇸 United States

    501-466 Swelab Alfa Lyse

    Reg #: 1064130 · FEI: 3002684533 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    Registration Number
    1064130
    FEI Number
    3002684533
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1800 N.W. 65TH AVE.
    City
    PLANTATION
    State
    FL
    ZIP
    33313
    Country
    US

    Owner / Operator

    Firm Name
    Boule Diagnostics AB
    Operator Number
    9034165
    Address
    Domnarvsgatan 4
    City
    Spanga
    State
    SE-NOTA
    Postal Code
    SE-163 53
    Country
    SE

    Products

    Device Name Product Code
    Products, Red-Cell Lysing Products GGK

    Proprietary Names

    501-466 Swelab Alfa Lyse Swelab Lumi-L1 Lyse 501-464 Medonic M-Series Lyse Swelab Lumi-L2 Lyse Medonic M51-L2 Lyse Medonic M51-L1 Lyse 501-475 Quintus 5-Part Lyse

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device