BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medonic M51-D Diluent

    Reg #: 1064130 · FEI: 3002684533 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    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
    Diluent, Blood Cell GIF

    Proprietary Names

    Medonic M51-D Diluent 501-057 CDS Hematology Diluent 501-133 CDS KX21 Hematology Diluent 501-208 Swelab Alfa Diluent 501-067 CDS HEMATOLOGY DILUENT 501-292 Quintus 5-Part Diluent 501-465 Swelab Alfa Diluent 501-476 Quintus 5-Part Diluent 501-212 Medonic M-Series Diluent 501-128 HEMATOLOGY DILUENT 501-202 CDS Hematology Diluent Cell-Dyn Emerald Diluent 501-003 HEMATOLOGY DILUENT 501-463 Medonic M-Series Diluent 501-052 CDS Hematology Diluent Swelab Lumi-D Diluent 501-201 CDS Hematology Diluent 501-069 CDS HEMATOLOGY DILUENT 501-081 CDS Diluent Sheath 501-056 CDS Hematology Diluent

    Establishment Types

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