Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000148879

FEI Number

3000148879

Entity Name

HORIBA ABX SAS

City/State/Country

MONTPELLIER Herault, FR

Establishment Address

PARC EUROMEDECINE, RUE DU CADUCEE, BP 7290, MONTPELLIER Herault 34184, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

HORIBA ABX SAS (Owner Number: 9036328)

Owner / Operator Contact Address

PARC EUROMEDECINE, RUE DU CADUCEE, BP 7290, MONTPELLIER, FR-NOTA 34184, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 UREA CP ABX PENTRA IRON CP ABX PENTRA URIC ACID 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 ABX PENTRA PHOSPHORUS CP Yumizen C1200 Amylase BIOCHEMISTRY SPARE PARTS AND CONSUMMABLES PENTRA C200 ABX PENTRA CALCIUM AS CP ABX PENTRA MULTICAL 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 GLUCOSE HK CP 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 ABX PENTRA MULTICAL 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2020-06-22
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-06-23
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2011-06-23
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2011-06-23
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2002-09-19
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2020-06-22
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2004-11-18
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2020-03-30
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2020-03-30
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2020-03-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2020-03-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2020-03-30
LED	Stains, Chemical Solution	Hematology	Class 1	864.1850	2004-12-01
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2006-10-05
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2020-07-10
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2020-07-10
DFT	Igm, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2020-07-10
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2020-07-10
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2021-06-02
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2021-06-02
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2007-10-24
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-10-24
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2020-05-13
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2020-03-19
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2020-03-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2006-10-05
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2006-10-05
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2006-10-05
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2006-10-05
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2014-12-23
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2007-06-28
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-06-28
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-06-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-06-28
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2007-06-28
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2020-03-19
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2020-03-19
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2020-03-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2020-07-02
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2020-07-03
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2008-03-03
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-05-07
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2011-05-26
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2007-12-03
KRY	Calibrator For Platelet Counting	Hematology	Class 2	864.8175	2015-11-24
KSA	Calibrator For Red-Cell And White-Cell Counting	Hematology	Class 2	864.8185	2015-11-24
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2015-11-24
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2015-11-24
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2020-07-02
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2002-09-19
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2007-12-03
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2024-05-30
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2020-06-19
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2007-06-28
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2007-06-28
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2007-06-28
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-06-28
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-06-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-06-28
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2006-10-05
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2006-10-05
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2006-10-05
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2006-10-05
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2006-10-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2006-10-05
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2006-10-05
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2006-10-05
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2006-10-05
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2006-10-05
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2006-10-05
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2006-10-05
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2006-10-05
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2016-12-28
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-05-28
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-05-28
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-05-28
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2018-11-28
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2002-09-19
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2020-06-22
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2006-10-05
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-05-09
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2008-05-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-05-09
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2008-05-09
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-05-09
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2008-05-09
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2011-11-14
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-11-14
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2011-11-14
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2011-11-14
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2011-11-14
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2013-07-17
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-07-17
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-07-17
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2007-03-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-03-14
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-03-14
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2007-03-14
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2007-03-14
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2007-03-14
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2006-10-05
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2006-10-05
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2006-10-05
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2014-02-06
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2020-06-23
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2006-10-05
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2020-03-19
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2024-05-30
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2006-10-05
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2006-10-05
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2006-10-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2006-10-05
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2006-10-05
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2006-10-05
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2006-10-05
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2006-10-05
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2006-10-05
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2006-10-05
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2006-10-05
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2006-10-05
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2014-03-11
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2018-02-06
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2014-07-09
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2020-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

Will Cripps Business: HORIBA Instruments Incorporated Email: william.cripps@horiba.com Phone: (800) 4459853

Related Public Records

Same Entity

HORIBA ABX SAS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000148879. Last updated year: 2026. Please use registration number 3000148879 when referencing this establishment in official correspondence.