Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8023024

FEI Number

6387

Entity Name

SEBIA

City/State/Country

EVRY Essonne, FR

Establishment Address

PARC TECHNOLOGIQUE LEONARD DE VINCI, EVRY Essonne 91008, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SEBIA (Owner Number: 8023024)

Owner / Operator Contact Address

PARC TECHNOLOGIQUE LEONARD DE, 27 rue Leonard de VINCI, Lisses-Evry, FR-NOTA 91008, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K063498

PMA Number

N/A

All Registered Proprietary Names

CAPILLARYS HB A1C USING CAPILLARYS 2 FLEX PIERCING HYDRAGEL ISO-CK CAPI3 HbA1c TERA, CAPI3 HbA1c OCTA Capillarys CDT -Capillarys 2 Flex Piercing Capillarys 2 flex piercing- Protein 6 Minicap Immunotyping using the Minicap Flex Piercing instrument Capillarys Urine CAPI 3 HEMOGLOBIN TERA, CAPI 3 HEMOGLOBIN OCTA HYDRASHIFT 2 /4 daratumumab Hb AFSA2 Control Hydragel CSF Isofocusing IT/IF Control CAPILLARYS NEONAT HB Hydragel Immunofixation FLC Kappa FLC Lambda HYDRAGEL CSF Gelscan Iso-Pal control HYDRAGEL ACID(E) HEMOGLOBIN(E) HYDRAGEL HEMOGLOBIN(E) Hb AFSC control CAPI3 HbA1c TERA, CAPI3 HbA1c OCTA CAPi3 HbA1c HYDRASHIFT 2/4 daratumumab and daratumumab control HYDRASHIFT 2/4 isatuximab Minicap HbA1c using the Minicap Flex Piercing Capillarys 2- Capillarys Hemoglobin CAPILLARYS IMMUNOTYPING USING CAPILLARY 2 AND CAPILLARY 2 FLEX PIERCING Capillarys 2 flex piercing- Capillarys Hemoglobin Capillarys HbA1c kit, Control, Calibrators with Capillarys 2 Flex Piercing Capillarys Immunotyping Capillarys Hemoglobin(e) HYDRAGEL HR Capi 3 Immunotyping TERA, Capi 3 Immunotyping OCTA Hydragel Bence Jones Kit Hydragel 18 A1AT ISOFOCUSING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2018-09-15
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-12-18
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2017-11-03
NAO	Test, Carbohydrate Deficient Transferrin	Clinical Chemistry	Class 1	862.1360	2012-07-24
JQJ	Densitometeric, Protein Fractionation	Clinical Chemistry	Class 1	862.1630	2012-06-07
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2016-11-09
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2016-11-09
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2016-11-09
CEF	Electrophoretic, Protein Fractionation	Clinical Chemistry	Class 1	862.1630	2016-11-09
JKM	Immunochemical, Bence-Jones Protein	Immunology	Class 2	866.5150	2008-07-23
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	2018-12-17
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2019-05-29
JCM	Control, Hemoglobin, Abnormal	Hematology	Class 2	864.7415	2023-07-24
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2008-07-23
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2012-06-08
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2012-06-08
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2012-06-08
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-06-08
CEF	Electrophoretic, Protein Fractionation	Clinical Chemistry	Class 1	862.1630	2012-06-08
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	2013-11-19
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2008-07-23
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2024-04-23
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2024-04-23
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2007-12-18
CFE	Electrophoretic, Lactate Dehydrogenase Isoenzymes	Clinical Chemistry	Class 2	862.1445	2013-11-19
JQT	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	Clinical Chemistry	Class 1	862.2400	2013-11-19
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	Clinical Chemistry	Class 2	862.1050	2013-11-19
JHY	Colorimetric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2013-11-19
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2008-07-23
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	2007-12-18
GIQ	Hemoglobin S	Hematology	Class 2	864.7415	2007-12-18
KQI	Assay, Fetal Hemoglobin	Hematology	Class 2	864.7455	2007-12-18
JBD	System, Analysis, Electrophoretic Hemoglobin	Hematology	Class 2	864.7440	2007-12-18
MLL	Hemoglobin C (Abnormal Hemoglobin Variant)	Hematology	Class 2	864.7415	2007-12-18
JCM	Control, Hemoglobin, Abnormal	Hematology	Class 2	864.7415	2008-07-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-02-21
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2017-02-21
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2018-08-15
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2018-08-15
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2021-11-15
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2018-09-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-09-16
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2018-09-16
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	2012-06-07
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2018-09-16
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2018-09-16
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2018-09-16
CEF	Electrophoretic, Protein Fractionation	Clinical Chemistry	Class 1	862.1630	2018-09-16
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	2012-06-07
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2012-12-18
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2012-12-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-12-18
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2008-07-23
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2008-07-23
CEF	Electrophoretic, Protein Fractionation	Clinical Chemistry	Class 1	862.1630	2008-07-23
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2008-07-23
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	2008-07-23
CEF	Electrophoretic, Protein Fractionation	Clinical Chemistry	Class 1	862.1630	1995-05-24
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2019-11-04
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	Class 2	866.5510	2019-11-04
CEF	Electrophoretic, Protein Fractionation	Clinical Chemistry	Class 1	862.1630	2019-11-04
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2019-11-04
JKM	Immunochemical, Bence-Jones Protein	Immunology	Class 2	866.5150	2008-05-13
OBZ	Alpha-1-Antitrypsin Kit, Qualitative Phenotype	Immunology	Class 2	866.5130	2008-07-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-07-23

Official Correspondent

Arnaud Collin

US Agent Details

Karen A Anderson Business: Sebia Email: karen.anderson@sebia-usa.com Phone: (404) 7881059

Related Public Records

Same Entity

SEBIA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003961883	INTERLAB S.R.L.	ROME Lazio, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171771	Siemens Healthcare Diagnostics, Inc.	ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay	2017-12-04
K820880	Miles Laboratories, Inc.	SERALYZER CK REAGENT STRIPS	1982-04-16
K771441	Instrumentation Laboratory CO	MULTISTAT III CPK TEST	1977-08-22
K822676	Amico Lab, Inc.	FITC ANTISERA TO HUMAN IGG	1982-11-17
K834595	Beckman Instruments, Inc.	PARAGON ACID HEMOGLOBIN REAGENT KIT	1984-05-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.
Z-0041-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
Z-0044-2013	Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom	2	IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0017-2012	Bio-Rad Laboratories, Inc.	2	D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8023024. Last updated year: 2026. Please use registration number 8023024 when referencing this establishment in official correspondence.