BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CLINICAL DIAGNOSTIC SOLUTIONS, INC.

    Reg #: 1064130 · FEI: 3002684533 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    45
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    Registration Number
    1064130
    FEI Number
    3002684533
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1800 N.W. 65TH AVE.
    City
    PLANTATION
    State
    FL
    ZIP
    33313
    Country
    US

    Regulatory Submissions

    510(k) Number
    K024173

    Owner / Operator

    Firm Name
    Boule Diagnostics AB
    Operator Number
    9034165
    Address
    Fagerstagatan 7
    City
    Spanga
    State
    SE-NOTA
    Postal Code
    SE-163 53
    Country
    SE

    Products

    Device Name Product Code
    Mixture, Hematology Quality Control JPK
    Products, Red-Cell Lysing Products GGK
    Flow Cytometric Reagents And Accessories. OYE
    Formulations, Balanced Salt Solutions KIP
    Detergent JCB
    Diluent, Blood Cell GIF
    Calibrator For Hemoglobin And Hematocrit Measurement KRZ
    Calibrator For Platelet Counting KRY
    Calibrator For Red-Cell And White-Cell Counting KSA
    General Purpose Reagent PPM

    Proprietary Names

    501-475 Quintus 5-Part Lyse Medonic M51-L1 Lyse 501-464 Medonic M-Series Lyse 501-466 Swelab Alfa Lyse Swelab Lumi-L2 Lyse Medonic M51-L2 Lyse Swelab Lumi-L1 Lyse 501-050 CDS SHEATH REAGENT 501-074 Enzymatic Cleaner Concentrate 501-477 Quintus 5-Part Stopper Cell-Dyn Emerald Cleaner 501-002 ENZYMATIC CLEANER 501-205 CDS Rinse Solution 501-350 Quintus 5-Part Stopper 501-036 Boule Cleaning Kit 501-029 Ac.T Cleaner and Shutdown Solution 501-204 CDS Rinse Solution 501-073 CDS DETERGENT REAGENT 501-064 CDS DETERGENT REAGENT 501-032 ENZYMATIC CLEANER 501-063 ENZYMATIC CLEANER CONCENTRATE Boule EasyCleaner 501-066 CDS DETERGENT REAGENT 501-292 Quintus 5-Part Diluent Cell-Dyn Emerald Diluent 501-202 CDS Hematology Diluent Medonic M51-D Diluent 501-057 CDS Hematology Diluent 501-069 CDS HEMATOLOGY DILUENT 501-465 Swelab Alfa Diluent 501-201 CDS Hematology Diluent 501-212 Medonic M-Series Diluent 501-052 CDS Hematology Diluent 501-056 CDS Hematology Diluent 501-081 CDS Diluent Sheath Swelab Lumi-D Diluent 501-128 HEMATOLOGY DILUENT 501-133 CDS KX21 Hematology Diluent 501-067 CDS HEMATOLOGY DILUENT 501-208 Swelab Alfa Diluent 501-463 Medonic M-Series Diluent 501-003 HEMATOLOGY DILUENT 501-476 Quintus 5-Part Diluent 501-028 Ac T Diff Reagent Pack 501-009 CDS 5-PD Reagent Set

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)