BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Beckman Coulter Ireland Inc

    Reg #: 9680746 · FEI: 1000206808 · Expires 2026
    View on FDA
    Products
    103
    Proprietary Names
    318
    Establishment Types
    3
    Classifications
    103

    Registration Details

    Registration Name
    Beckman Coulter Ireland Inc
    Registration Number
    9680746
    FEI Number
    1000206808
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LISMEEHAN
    City
    O CALLAGHANS MILLS Clare
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K041793

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US

    US Agent

    Business Name
    Beckman Coulter, Inc.
    Contact Name
    Ian Pilcher
    Address
    1000 Lake Hazeltine Dr
    City
    Chaska
    State
    MN
    ZIP
    55318
    Country
    US
    Email
    [email protected]
    Phone
    443 3506459

    Products

    Device Name Product Code
    Anti-Müllerian Hormone Test System PQO
    Ferrozine (Colorimetric) Iron Binding Capacity JMO
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Bromcresol Green Dye-Binding, Albumin CIX
    Colorimetric Method, Cpk Or Isoenzymes JHY
    Calibrator, Multi-Analyte Mixture JIX
    Method, Nephelometric, Immunoglobulins (G, A, M) CFN
    Turbidimetric Method, Lipoproteins JHN
    System, Test, Beta-2-Microglobulin Immunological JZG
    Radioimmunoassay, Total Triiodothyronine CDP
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Ferritin, Antigen, Antiserum, Control DBF
    Hexokinase, Glucose CFR
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Calibrator, Secondary JIT
    Acid, Lactic, Enzymatic Method KHP
    Calibrator, Primary JIS
    Fluorometric Method, Cpk Or Isoenzymes JHX
    Immunoassay Method, Troponin Subunit MMI
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Myoglobin, Antigen, Antiserum, Control DDR
    Complement C4, Antigen, Antiserum, Control DBI
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    System, Test, Thyroid Autoantibody JZO
    Radioassay, Vitamin B12 CDD
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    System, Test, C-Reactive Protein DCN
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Blood, Occult, Colorimetric, In Urine JIO
    Test, Urine Leukocyte LJX
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Refractometer For Clinical Use JRE
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Automated Urinalysis System KQO
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Radioimmunoassay, Parathyroid Hormone CEW
    System, Test, Human Chorionic Gonadotropin DHA
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Prealbumin, Fitc, Antigen, Antiserum, Control DDS
    System, Test, Vitamin D MRG
    Photometric Method, Magnesium JGJ
    Haptoglobin, Antigen, Antiserum, Control DAD
    Azo Dye, Calcium CJY
    Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control LKL
    Alpha-1-Antitrypsin, Antigen, Antiserum, Control DEM
    Colorimetry, Cholinesterase DIH
    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions MTG
    Assay, Glycosylated Hemoglobin LCP
    Cardiac C-Reactive Protein, Antigen, Antiserum, And Control NQD
    Ceruloplasmin, Antigen, Antiserum, Control DDB
    Starch-Dye Bound Polymer, Amylase CIW
    General Purpose Reagent PPM
    Radioimmunoassay (Two-Site Solid Phase), Ferritin JMG
    Qualitative And Quantitative Hepatitis B Virus Antibody Assays SEI
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Enzymatic, Carbon-Dioxide KHS
    System, Test, Rheumatoid Factor DHR
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Hepatitis A Test (Antibody And Igm Antibody) LOL
    Assayed Quality Control Material For Clinical Microbiology Assays QCH
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer MTF
    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) LOM
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Enzyme Immunoassay, Phenobarbital DLZ
    Electrode, Ion Specific, Potassium CEM
    Bromcresol Purple Dye-Binding, Albumin CJW
    Conductivity Rate, Urea Nitrogen LFP
    Electrode, Ion Specific, Sodium JGS
    Enzyme Immunoassay, Benzodiazepine JXM
    Biuret (Colorimetric), Total Protein CEK
    Glucose Oxidase, Glucose CGA
    Photometric Method, Iron (Non-Heme) JIY
    Ph Rate Measurement, Carbon-Dioxide JFL
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Electrode, Ion Specific, Calcium JFP
    Diazo Colorimetry, Bilirubin CIG
    Radioimmunoassay, Free Thyroxine CEC
    Radioimmunoassay, Luteinizing Hormone CEP
    Products, Red-Cell Lysing Products GGK
    Acid, Folic, Radioimmunoassay CGN
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Albumin, Antigen, Antiserum, Control DCF
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Hemoglobin A1c Test System PDJ
    Transferrin, Rhodamine, Antigen, Antiserum, Control DDD
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Fibrin Split Products GHH
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Ige, Antigen, Antiserum, Control DGC
    Acid, Uric, Uricase (Colorimetric) KNK
    Radioimmunoassay, Estradiol CHP
    Complement C3, Antigen, Antiserum, Control CZW
    Test, Hiv Detection MZF

    Proprietary Names

    Access AMH (P/N: B13127 IE MFG) OSR61205 UIBC Access TSH (3rd IS) (P/N: B63284 MN and IE MFG) DxI 9000 Immunoassay Analyzer (P/N: C11137) Access TSH (3rd IS) (P/N: C28643 MN MFG) OSR6102 ALBUMIN OSR6202 ALBUMIN OSR6602 ALBUMIN OSR61155 CK-MB ODR3021 SERUM PROTEIN MULTI-CALIBRATOR 1 OSR61172 IgG OSR61172x IgG ODR3022 APO A1 & B CALIBRATOR OSR6142 APO A1 OSR6151 β-2 MICROGLOBULIN Access Free T3 (P/N: A13422 MN and IE MFG) OSR6119 GLUTAMYLTRANSFERASE (GGT) OSR6219 GAMMA-GLUTAMYLTRANSFERASE (GGT) OSR6179 CK (NAC) OSR6279 CK (NAC) OSR61118 TRIGLYCERIDE OSR60118 TRIGLYCERIDE OSR66118 TRIGLYCERIDE OSR61203 FERRITIN OSR6221 GLUCOSE OSR6121 GLUCOSE OSR6621 GLUCOSE OSR6695 HDL-CHOLESTEROL OSR6295 HDL-CHOLESTEROL OSR6195 HDL-CHOLESTEROL ODC0023 HDL CHOLESTEROL CALIBRATOR OSR6193 LACTATE Access CK-MB (P/N: 386371 MN and IE MFG) Access CK-MB Calibrators (P/N: 386372 MN MFG) Access hsTnI (P/N: B52699 MN and IE MFG) System calibrator 66300X Bicarbonate calibrator ODC0019 Access TSH (3rd IS) Calibrators (P/N: B63285 MN MFG) OSR6209 AST OSR6609 AST OSR6109 AST OSR6509 AST Access Myoglobin (P/N: 973243 MN and IE MFG) Access Myoglobin Calibrators (P/N: 973244 MN MFG) OSR6160 C4 476841 Lactate Dehydrogenase Reagent (LD 2 x 300) 442655 Lactate Dehydrogenase Reagent (LD 2 x 200) 442660 Lactate Dehydrogenase Reagent (LD-P 2 x 200) A95550 Lactate Reagent (LACT 2 x 50) SYNCHRON Lactate OSR6127 LACTATE DEHYDROGENASE OSR6227 LACTATE DEHYDROGENASE OSR61173 IgM Access TPO Antibody (P/N: A12985 MN and IE MFG) ODR3029 PREALBUMIN CALIBRATOR Access Vitamin B12 (P/N: 33000 MN and IE MFG) Access Vitamin B12 Calibrators (P/N: 33005 MN MFG) Access Vitamin B12 S0 Calibrator (P/N: 33006 MN MFG) OSR6134 UREA/UREA NITROGEN OSR6234 UREA/UREA NITROGEN OSR6634 UREA/UREA NITROGEN OSR6147 CRP iChemVELOCITY Automated Urine Chemistry System (800-7167) Stand-Alone iChemVELOCITY (800-7719) iChemVELOCITY Automated Urine Chemistry System w load/unload (800-7166) iChemVELOCITY Computerless (800-3530) Back-Integrated iChemVELOCITY (800-7720) iChemVELOCITY Urine Chemistry Strips (800-7212) UA Win10 Kit (C52900) Access Intact PTH (P/N: A16972 MN and IE MFG) Access Total bhCG (5th IS) (P/N: A85264 MN and IE MFG) Access Total bhCG (5th IS) Calibrators (P/N: B11754 MN MFG) Access AMH QC (P/N: B13129) Access AMH Calibrators (P/N: B13128) OSR6122 INORGANIC PHOSPHOROUS OSR6222 INORGANIC PHOSPHOROUS ODC0003 Control Serum 1 ODC0004 Control Serum 2 ODC0005 HDL/LDL Cholesterol Control Serum (Level 1-2) 3x5 mL OSR6175 PREALBUMIN Access 25(OH) Vitamin D Total for Use on the Access 2 Immunoassay System (P/N: B24838 MN and IE MFG) Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immunoassay System. (P/N: B24839 MN MFG) OSR6189x MAGNESIUM OSR6189 MAGNESIUM OSR6165 HAPTOGLOBIN 988413 Haptoglobin Reagent (HPT 2 x 100) QUANTIPLATE OR ENDOPLATE TM HA OSR61117 CALCIUM ARSERAZO OSR66117 CALCIUM ARSENAZO OSR60117 CALCIUM ARSENAZO OSR65117 CALCIUM (Arsenazo) OSR6162 α-1 ACIDGLYCOPROTEIN OSR6163 α-1 ANTITRYPSIN DR0090 URINE CHEMISTRY CALIBRATOR DR0091 URINE CREATININE CALIBRATOR DR0070-1 LYOPHILIZED CHEMISTRY CALIBRATOR LEVEL 1 DR0070-2 LYOPHILIZED CHEMISTRY CALIBRATOR LEVEL 2 ODR3023 SERUM PROTEIN MULTI-CALIBRATOR 2 OSR6114 CHOLINESTERASE Access Hybritech free PSA (P/N: 37210 MN and IE MFG) Access Hybritech Free PSA Calibrators (P/N: 37215 MN MFG) Access Hybritech free PSA (P/N: C22846 MN MFG) Access 25(OH) Vitamin D Total (A98856 MN and IE MFG) Access 25(OH) Vitamin D Total (C28646 MN MFG) Access Total ?hCG (5th IS) (P/N: A85264 MN and IE MFG) Access Total ?hCG (5th IS) (P/N: C28645 MN MFG) B00389 HbA1c Access Intact PTH Calibrators (P/N: A16953 FR MFG) ODC0027 CRP LATEX CALIBRATOR HIGHLY SENSITIVE (HS) SET ODC0026 CRP LATEX CALIBRATOR NORMANL (N) SET OSR6199 CRP LATEX Ceruloplasmin OSR6106 ALPHA-AMYLASE OSR6006 ALPHA-AMYLASE Access TPO Antibody Calibrators (P/N: A18227 FR MFG) PerFix NC Kit (Fixative Reagent) 447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4 A28945 SYNCHRON Systems ISE Electrolyte Buffer 657133 Cartridge Chemistry Wash Solution (CCWA 2 x 300) UniCel DxI Wash Buffer II OnBoard Dilution Kit (A79784 MN MFG) 445865 SYNCHRON Systems Wash Concentrate II 472137 SYNCHRON and AU Systems Hemolyzing Reagent 447650 IMMAGE Immunochemistry Systems BUF 1 Buffer 1 Iris® System Cleanser Pack (800-3203) 447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3 447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2 598190 598190 Trace-Klean Ready to Use Cleaning Solution 447660 IMMAGE Immunochemistry Systems DIL 2 Diluent 2 589784 Trace-Klean Concentrated Cleaning Solution A28937 SYNCHRON Systems ISE Electrolyte Reference A88469 HbDIL DxC iChem® VELOCITY™ Wash Solution Case of 2 x 7L (800-7217) Iris® Diluent Pack (800-3202) 467826 Sample Diluent 1 DIL1 447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1 469110 Synchron Systems NO FOAM 447060 IMMAGE Immunochemistry Systems Wash Solution 445967 SYNCHRON CX Systems Antifoam 442831 PVT 2, 472055 PVT 5, 442830 PVT 3 DTCS Quick Start Kit DNA Size Standard Kit - 400 DNA Size Standard Kit - 600 Separation Buffer SEPARATION GEL-LPA I CEQ Sample Loading Solution Separation Gel – LPAI DNA Sequencing Separation Buffer Sample Loading Solution (SLS) DNA Size Standard Kit - 80 GenomeLab GeXP Start Kit iQ Body Fluids Lysing Reagent (800-3213) iQ Lamina 2 x 7L (800-3236) iQ Body Fluids Conical Tubes (800-3215) 66039 Cleaning Solution 664090 CLENZ Solution Access Wash Buffer II ( P/N: A16972 KY and DE MFG) Access Substrate (P/N: 81906 MN MFG) Flow Check Pro Fluorospheres UniCel DxI Access Wash Buffer II (P/N: A16973 KY and DE MFG) Access Sample Diluent A (P/N: 81908 MN MFG) FLOW-CHECK Access Sample Diluent A (Onboard Reagent Kit) (P/N: A79783 MN MFG) LumiPhos PRO Substrate (P/N: B96000 MN MFG) DxFLEX Daily QC Fluorospheres ODR2000 5L WASH SOLUTION OSR62166 LIH OSR0001 WASH SOLUTION 657197 Synchron AUTO-GLOSS CTS Access Ferritin (P/N: C22490) Access Ferritin (P/N: 33020) ACCESS anti-HBc IgM, Access anti-HBc IgM Calibrator, Access anti-HBc IgM QC OSR6678 CREATININE OSR6178 CREATININE OSR6137 BICARBONATE OSR6237 BICARBONATE OSR6537 BICARBONATE OSR6637 BICARBONATE ODC0028 RF LATEX CALIBRATOR OSR61105 RF LATEX Access Prolactin (P/N: 33530 MN and IE MFG) Access Prolactin Calibrators (P/N: 33535 MN MFG) Access anti-HAV Calibrator Access anti-HAV Access anti-HAV QC Access Hybritech PSA Sample Diluent (P/N: 37206 MN MFG) Access Hybritech PSA (P/N: 37200 MN and IE MFG) Access Hybritech PSA Calibrators (P/N: 37205 MN MFG) Access Hybritech PSA (P/N: C22845 MN MFG) Access HBsAg Calibrator Access HBsAg Confirmatory Access HBsAg QC Access HBsAg 447480 IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent 447620 IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent 469165 Antistreptolysin-O Reagent (ASO- 2 x 100) OSR6194 ASO 467858 SYNCHRON Systems Albumin Reagent SYNCHRON Systems Glucose Reagent (Glucose Oxidase) SYNCHRON Systems CO2 Alkaline Buffer Synchron Systems Total Protein Reagent SYNCHRON Systems Phosphorus Reagent SYNCHRON Systems CO2 Acid Reagent SYNCHRON Systems Urea Nitrogen (BUN) Reagent NA+ Electrode UniCel DxC 600 PRO, Recon UniCel DxC 600, Recon UniCel DxC 800 PRO, Recon UniCel DxC 800, Recon Calcium Electrode CO2 Electrode Chloride Electrode Potassium Electrode OSR6111 DIRECT BILIRUBIN OSR6611 DIRECT BILIRUBIN OSR6511 DIRECT BILIRUBIN OSR6211 DIRECT BILIRUBIN OSR6112 TOTAL BILIRUBIN OSR6612 TOTAL BILIRUBIN OSR6512 TOTAL BILIRUBIN OSR6212 TOTAL BILIRUBIN Access Free T4 (P/N: 33880 MN and IE MFG) Access Free T4 Calibrators (P/N: 33885 MN MFG) ACCESS anti-HAV IgM QC 2x4 mL (3 ea) US (D25836) ACCESS anti-HAV IgM 2x100 DET US (D25834) ACCESS anti-HAV IgM Calibrator 1x2 mL US (D25835) Access hLH Calibrators (P/N: 33515 MN MFG) Access hLH (P/N: 33510 MN and IE MFG) PerFix NC Kit (Lysing Reagent) IRIS BODY FLUIDS LYSING REAGENT AQUIOS Lysing Reagent Kit Fixative Solution (10X) OptiLyse C : Lysing Solution Lysing Solution (10X) IntraPrep Reagent 2: Permeabilization IOTest 3 Fixative VersaLyse : Lysing Solution IOTest 3 Lyse DxH 500 Series Lyse (PN B36846) Whole Blood Lysing Reagent COULTER Rinsol Cleaning Agent DxH Cell Lyse 1L & 5L AcT 5diff Fix DxH Retic Pack IMMUNOPREP REAGENT DxH diff Pack AcT 5diff Hgb Lyse COULTER DxH Cell Lyse DxH ECO Cell Lyse (5L) AcT 5diff WBC Lyse Access Red Blood Cell Folate Lysing Agent DxH ECO Cell Lyse (1L) Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG) Access Folate (P/N: A98032 MN and IE MFG) OSR6186 IRON OSR6286 IRON A53722 Synchron Cholinesterase (CHEX) Reagent OSR6604 ALP OSR6004 ALP OSR6104 ALP OSR6504 ALP OSR6204 ALP Access Ferritin Calibrators (P/N: 33025) OSR6296 LDL-CHOLESTEROL OSR6196 LDL-CHOLESTEROL ODC0024 LDL CHOLESTEROL CALIBRATOR B38858 URINE/CSF ALBUMIN B38859 URINE/CSF ALBUMIN CALIBRATOR B46435 URINE/CSF ALBUMIN OSR6607 ALT OSR6107 ALT HbA1c Advanced OSR6152 TRANSFERRIN OSR6616 CHOLESTEROL 467825 Cholesterol Reagent (CHOL 2 x 300) SYNCHRON Cholesterol OSR6516 CHOLESTEROL OSR6216 CHOLESTEROL OSR6116 CHOLESTEROL BECKMAN ENZYMATIC CH OSR6132 TOTAL PROTEIN LIQUID - STAT TOTAL PROTEIN REAGENT 465986 SYNCHRON Systems Total Protein Reagent OSR6170 URINARY/CSF PROTEIN OSR6232 TOTAL PROTEIN OSR6270 URINARY/CSF PROTEIN OSR6632 TOTAL PROTEIN OSR60135 D-DIMER ODC0029 D-DIMER CONTROL ODR3033 D-DIMER CALIBRATOR 465365 Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 447450 IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent Access Free T4 (P/N: C76421 MN and IE MFG) OSR6130 LIPASE OSR6230 LIPASE OSR61181 DIRECT BILIRUBIN Access hFSH (P/N: 33520 MN and IE MFG) Access hFSH Calibrators (P/N: 33525 MN and IE MFG) Total Immunoglobulin E (IgE) - C22529 OSR 6098 URIC ACID OSR6298 URIC ACID OSR6698 URIC ACID OSR6198 URIC ACID Access anti-HBc Total Access anti-HBc Total Calibrator Access anti-HBc Total QC Access Sensitive Estradiol (P/N: B84493 IE MFG) Access Estradiol (33540 MN ans IE MFG) OSR6143 APO B OSR61171 IgA Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel DxI Immunoassay System (P/N: A98857 MN MFG) Access 25(OH) Vitamin D Total for Use on the UniCel DxI Immunoassay System (P/N: A98856 MN and IE MFG) AUH1011 ISE Buffer AUH1018 Selectivity Check Na/K AUH1016 High/Low Urine Standard AUH1015 High Serum Standard AUH1013 Reference Solution AUH1014 Low Serum Standard AUH1017 Internal Ref. Solution AUH1012 Mid Standard OSR6159 C3 Access HIV Ag/Ab combo QC (P/N: C39452) Access HIV Ag/Ab combo Calibrators (P/N: C39451) Access HIV Ag/Ab combo (P/N: C39450)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility