BEUDAMED
    FDA Registration Active 🇫🇷 France

    HORIBA ABX SAS

    Reg #: 3000148879 · FEI: 3000148879 · Expires 2026
    View on FDA
    Products
    63
    Proprietary Names
    187
    Establishment Types
    6
    Classifications
    63

    Registration Details

    Registration Name
    HORIBA ABX SAS
    Registration Number
    3000148879
    FEI Number
    3000148879
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PARC EUROMEDECINE, RUE DU CADUCEE, BP 7290
    City
    MONTPELLIER Herault
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K081276

    Owner / Operator

    Firm Name
    HORIBA ABX SAS
    Operator Number
    9036328
    Address
    PARC EUROMEDECINE, RUE DU CADUCEE, BP 7290
    City
    MONTPELLIER
    State
    FR-NOTA
    Postal Code
    34184
    Country
    FR

    US Agent

    Business Name
    HORIBA Instruments Incorporated
    Contact Name
    Will Cripps
    Address
    5449 Research Drive, Canton, MI 48188
    City
    Canton
    State
    MI
    ZIP
    48188
    Country
    US
    Email
    [email protected]
    Phone
    800 4459853

    Products

    Device Name Product Code
    Calibrator, Primary JIS
    Hexokinase, Glucose CFR
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Acid, Uric, Uricase (Colorimetric) KNK
    Diluent, Blood Cell GIF
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Calculator/Data Processing Module, For Clinical Use JQP
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Stains, Chemical Solution LED
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    Iga, Antigen, Antiserum, Control CZP
    Igg, Antigen, Antiserum, Control DEW
    Igm, Antigen, Antiserum, Control DFT
    Method, Nephelometric, Immunoglobulins (G, A, M) CFN
    Enzymatic Method, Creatinine JFY
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Bromcresol Green Dye-Binding, Albumin CIX
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Calibrator, Multi-Analyte Mixture JIX
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Acid, Lactic, Enzymatic Method KHP
    Counter, Differential Cell GKZ
    Myoglobin, Antigen, Antiserum, Control DDR
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Calibrator, Secondary JIT
    Photometric Method, Iron (Non-Heme) JIY
    Transferrin, Antigen, Antiserum, Control DDG
    Ferritin, Antigen, Antiserum, Control DBF
    System, Test, Rheumatoid Factor DHR
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) JIQ
    Biuret (Colorimetric), Total Protein CEK
    Calibrator For Platelet Counting KRY
    Calibrator For Red-Cell And White-Cell Counting KSA
    Calibrator For Hemoglobin And Hematocrit Measurement KRZ
    Calibrator For Cell Indices KRX
    General Purpose Reagent PPM
    Mixture, Hematology Quality Control JPK
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Albumin, Antigen, Antiserum, Control DCF
    Cresolphthalein Complexone, Calcium CIC
    Photometric Method, Magnesium JGJ
    Enzymatic, Carbon-Dioxide KHS
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Products, Red-Cell Lysing Products GGK
    Prealbumin, Antigen, Antiserum, Control JZJ
    Catalytic Methods, Amylase JFJ
    Azo Dye, Calcium CJY
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    System, Test, Low Density, Lipoprotein MRR
    Ldl & Vldl Precipitation, Hdl LBR
    Diazo Colorimetry, Bilirubin CIG
    Stains, Hematology KQC
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Slide Stainer, Automated KPA
    Counter, Cell, Automated (Particle Counter) GKL
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA

    Proprietary Names

    Yumizen C1200 CRPhs Cal Yumizen C1200 Micro Alb U/CSF Cal Normal Yumizen C1200 CRP Cal Yumizen C1200 Micro Alb U/CSF Cal High ABX Pentra CRP HS Cal ABX PENTRA URIC ACID CP ABX PENTRA GLUCOSE HK CP ABX DILUENT (10L) ABX DILUENT (20L) ABX MINIDIL LMG (20L) ABX MINIDIL LMG (10L) Yumizen C1200 Cholesterol YUMIZEN P8000 Cl- Chloride Electrode Yumizen C1200 AL Na+ Sodium Electrode K+ Potassium Electrode Yumizen C1200 Glucose HK Yumizen C1200 ABX FLUOCYTE (0.5L) ABX RETIX (0.5L) ABX PENTRA LIPASE CP Yumizen C1200 Lipase Yumizen C1200 Immunoglobulin M Yumizen C1200 Immunoglobulin A Yumizen C1200 Immunoglobulin G Yumizen C1200 Creatinine PAP ABX PENTRA UREA CP Yumizen C1200 Urea Yumizen C1200 P multi Control ABX Pentra N MultiControl ABX Pentra P MultiControl Yumizen C1200 U/CSF L2 Micro Alb Control Yumizen C Urine Level 1 Control Yumizen C Level 1 HbA1c Control Yumizen C1200 Level 2 CRPhs Control Yumizen C1200 Level 1 CRPhs Control Yumizen C1200 N multi Control Yumizen C Level 2 HbA1c Control Yumizen C1200 Level 1 Protein Control Yumizen C Urine Level 2 Control Yumizen C1200 Level 2 Protein Control Yumizen C1200 U/CSF L1 Micro Alb Control Yumizen C1200 Albumin Yumizen C1200 ALP ABX PENTRA AST CP ABX PENTRA LACTIC ACID Yumizen C1200 Lactate ABX MICROS ES 60 OT ABX MICROS ES 60 CT ABX MICROS ES60 ABX PENTRA CK NAC CP Yumizen C1200 CK-NAC Yumizen C1200 Rheumatoid Factor Yumizen C1200 Ferritin Yumizen C1200 Transferrin Yumizen C1200 Apo Cal Yumizen C1200 Ferritin Cal Yumizen C1200 HDL Cal Yumizen C1200 RF Cal Yumizen C1200 C02 Cal Yumizen C1200 LDL Cal ABX Pentra RF Cal Yumizen C1200 TPU Cal Yumizen C1200 AST ABX PENTRA LDH IFCC CP ABX Pentra LDH CP ABX PENTRA URINARY PROTEINS CP Yumizen C1200 Urinary Proteins Yumizen C1200 Total Protein ABX Pentra TOTAL PROTEIN 100 CP (Ref. A11A01932) ABX MICROS 60 ABX MINOCAL Yumizen C HbA1c Cal Yumizen C1200 Multi Cal Yumizen C1200 Protein Cal ABX PENTRA ISE CLEANER CP ABX CLEANER (1L) ABX MINICLEAN (1L) ABX MINOCLAIR (0.5L) ABX MINIPACK LMG Yumizen C1200 Pyridoxal-5-Phosphate ABX PENTRA XL80 HEMATOLOGY SPARE PARTS OR CONSUMABLES BFTROL Yumizen C1200 C02 Control ABX PENTRA ALBUMIN CP ABX PENTRA TOTAL PROTEIN CP ABX PENTRA MAGNESIUM RTU ABX PENTRA MULTICAL ABX PENTRA CO2 RTU ABX PENTRA ALP CP ABX PENTRA PHOSPHORUS CP ABX PENTRA IRON CP ABX PENTRA CO2 CONTROL Yumizen C1200 C02 Yumizen C1200 Magnesium ABX PENTRA CO2 CAL ABX PENTRA PRECITEST SOLUTION ABX Pentra Creatinine 120 CP ABX Pentra Multical ABX Minotrol 16 MINILYSEBIO (0.4L) WHITEDIFF (1L) ABX MINILYSE LMG (1L) ABX EOSINOFIX (1L) ABX LYSEBIO (0.4L) ABX BASOLYSE ABX LYSEBIO (1L) ABX LEUCODIFF (1L) ABX ALPHALYSE 360mL ABX MINILYSE ABX BASOLYSE II NUCEDIFF (1L) ABX Alphalyse 0.4L Yumizen C1200 Iron Yumizen C1200 Prealbumin ABX CRP CAL ABX PENTRA AMYLASE CP Yumizen C1200 Amylase BIOCHEMISTRY SPARE PARTS AND CONSUMMABLES PENTRA C200 ABX PENTRA CALCIUM AS CP ABX PENTRA HDL DIRECT CP ABX PENTRA HDL CAL ABX PENTRA TRIGLYCERIDES CP ABX PENTRA CHOLESTEROL CP ABX PENTRA LDL CAL ABX PENTRA LDL DIRECT CP ABX PENTRA HDL DIRECT 100 CP Yumizen C1200 HDL Direct Yumizen C1200 LDL Direct ABX PENTRA BILIRUBIN, TOTAL CP ABX PENTRA BILIRUBIN, DIRECT CP Yumizen C1200 Direct Bilirubin Yumizen C1200 Total Bilirubin Yumizen C1200 Phosphate ABX PENTRA GGT CP Yumizen C1200 GGT Yumizen C1200 CRP Yumizen H2500 ABX CRP REA ABX CRP STD PENTRA C400 STD ABX PENTRA POTASSIUM-E PENTRA C400 ISE I.S.E. MODULE ABX PENTRA REFERENCE CUVETTE SEGMENTS RACK ABX PENTRA SODIUM-E ABX PENTRA STANDARD 2 ABX PENTRA REFERENCE-E ABX PENTRA CHLORIDE-E ABX PENTRA CLEAN-CHEM 99 CP ABX PENTRA CLEAN-CHEM CP SAMPLE CUP - GREEN ABX PENTRA STANDARD 1 ABX PENTRA ETCHING CP SAMPLE CUP - YELLOW ABX PENTRA GLUCOSE PAP CP SAMPLE CUP - BLUE ABX PENTRA DEPROTEINIZER CP SAMPLE CUP - WHITE ABX PENTRA REFERENCE 280ml BIOCHEMISTRY SPARE PARTS OR CONSUMABLES ABX Pentra Micro ALB 2 Cal (Ref.1300032565) ABX Pentra Micro ALBUMIN 2 CP (Ref.1300032563) YUMIZEN T6000 furniture modules Yumizen T6000 ABX MINOTROL CRP Yumizen C1200 Triglycerides ABX PENTRA TPU CAL Yumizen C1200 Uric Acid ABX MINOTROL RETIC Yumizen C1200 Creatinine Jaffe Yumizen C1200 Calcium AS YUMIZEN SPS ABX Pentra Enzymatic Creatinine CP PENTRA XLR ABX DIFFTROL ABX PENTRA CRP CAL ABX PENTRA LOW CRP CONTROL ABX PENTRA CRP CP ABX PENTRA IMMUNO I CONTROL L/H ABX PENTRA ALT CP Yumizen C1200 ALT ABX PENTRA 60 C+

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device