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Develops and manufactures in-vitro diagnostic systems and reagents for electrophoresis, ELISA and immunofluorescence

SE

Sebia

Lisses (France) · Training centers: Brazil, Singapore, UAE, USANew on Amplifa

1967Founded by Guy Barouh
1.300Employees worldwide
over 20,000Instruments installed worldwide
over 120Countries covered by sales
22Subsidiaries and representative offices

About Sebia

Sebia is a globally specialized provider in the field of in-vitro diagnostics (IVD) headquartered in Lisses south of Paris. The company develops, manufactures and distributes instruments and reagents for the screening and monitoring of various diseases, primarily in the areas of oncology (multiple myeloma), diabetes, hemoglobinopathies as well as autoimmune and infectious diseases and other rare pathologies. The technical foundation comprises four method families: capillary electrophoresis (CAPILLARYS and MINICAP systems), agarose gel electrophoresis (HYDRASYS 2), ELISA with the patented SMC technology (Alegria 2) and indirect immunofluorescence (dIFine systems). More than 20,000 instruments are installed worldwide, and the company covers more than 120 countries. The products are CE-marked; the quality management system is certified to ISO 13485:2016 and meets MDSAP requirements. In addition, Sebia offers support in maintenance, training and laboratory optimization through Sebia Service, Sebia Academy and Sebia Lean Service.

Site
Lisses, France
Processes
Capillary Electrophoresis (CE), Gel Electrophoresis (Agarose Gel), ELISA (Enzyme-Linked Immunosorbent Assay), Indirect Immunofluorescence Assays (IFA), SMC Technology (Sensotronic Memorized Calibration) - Alegria Monotest, HbA1c test, Immunofixation / Immunotyping, Fecal calprotectin test
Materials
Capillary Electrophoresis, Agarose Gel Electrophoresis, ELISA / SMC Technology, Indirect Immunofluorescence
Certificates
ISO 13485:2016, MDSAP-compliant, CE marking (IVD products)
Founded
1967
Employees
1.300
Industries
In-vitro diagnostics (IVD), Oncology (multiple myeloma), Diabetes, Hemoglobinopathies, Autoimmune diseases, Infectious diseases
  1. 01

    R&D and development of diagnostic systems and tests

  2. 02

    Manufacturing of instruments and reagents

  3. 03

    Regulatory approval and CE marking

  4. 04

    Distribution via subsidiaries and distributors

  5. 05

    Installation, maintenance and calibration (Sebia Service)

  6. 06

    Training and scientific support (Sebia Academy, Knowledge Center)

  7. 07

    Lean management consulting for laboratories (Sebia Lean Service)

Methods and Technologies

CE

Capillary Electrophoresis

Automated, high-resolution separation of proteins and hemoglobin variants in serum, urine and other body fluids.

GEL

Agarose Gel Electrophoresis

Separation of proteins by charge, isoelectric point or molecular weight, among other applications for immunofixation and multimer analyses.

ELISA

ELISA / SMC Technology

Enzyme immunoassays with individually barcoded monotest strips for traceability and integrated cut-off control in autoimmune and infectious disease diagnostics.

IFA

Indirect Immunofluorescence

Detection of autoantibodies, including ANA screening on HEp-2 cells, with digital image evaluation (dIFine).

Locations

Lisses

FR

Headquarters, manufacturing, R&D and training center

  • CAPILLARYS 3 OCTA
  • CAPILLARYS 3 TERA
  • CAPILLARYS 3 TERA MC
  • CAPILLARYS 3 TERA TLA
  • CAPILLARYS 3 DBS
  • MINICAP FLEX-PIERCING
  • HYDRASYS 2 SCAN FOCUSING
  • Alegria 2
  • dIFine automated microscope
  • dIFine P30 processor

Industries

In-vitro diagnostics (IVD)Oncology (multiple myeloma)DiabetesHemoglobinopathiesAutoimmune diseasesInfectious diseasesRare diseasesNeurology (multiple sclerosis)

Processes & technical limits

ProcessesToleranceMax. partWeightLot sizeMaterials
Capillary Electrophoresis (CE)Testing––––Serum, Urine, other biological fluids, CSF
Gel Electrophoresis (Agarose Gel)Testing––––Serum, Urine, other biological fluids
ELISA (Enzyme-Linked Immunosorbent Assay)Testing––––Liquid samples (serum etc.)
Indirect Immunofluorescence Assays (IFA)Testing––––Patient serum
SMC Technology (Sensotronic Memorized Calibration) - Alegria MonotestTesting–––––
HbA1c testTesting–––––
Immunofixation / ImmunotypingTesting–––––
Fecal calprotectin testTesting––––Stool
CDT measurement (Carbohydrate-deficient Transferrin)Testing–––––
ISO 13485:2016 certified quality management system, MDSAP-compliantTesting–––––
Sebia Lean Service (Lean management consulting)Engineering–––––
Sebia Service (support, training, maintenance, calibration)Assembly–––––

11 Anlagen & Maschinen

MachineManufacturer / modelQuantityWorking areaYear builtSite
Capillary electrophoresis systemSebia CAPILLARYS 3 OCTA––––
Capillary electrophoresis systemSebia CAPILLARYS 3 TERA––––
Capillary electrophoresis systemSebia CAPILLARYS 3 TERA MC––––
Capillary electrophoresis system (TLA)Sebia CAPILLARYS 3 TERA TLA––––
Capillary electrophoresis system (DBS)Sebia CAPILLARYS 3 DBS––––
Capillary electrophoresis system (compact)Sebia MINICAP FLEX-PIERCING––––
Multifunctional gel electrophoresis analyzerSebia HYDRASYS 2 SCAN FOCUSING––––
Automated immunoassay analyzer (ELISA/SMC)Sebia (Orgentec) Alegria 2––––
Automated microscope (IFA imaging)Sebia (ZEUS Scientific) dIFine® automated microscope––––
Benchtop instrument for IFA slide handlingSebia (ZEUS Scientific) dIFine® P30 processor––––
Capillary electrophoresis systemSebia CAPILLARYS 2––––

Additional services

Sebia Service (technical support, maintenance, repair, calibration)Sebia Academy (training, webinars, e-learning)Software for data analysis and interpretationTraining for partners and customers

Reference customers

Emory Healthcare, Atlanta (webinar speaker / Emory University Hospital)University Hospital of Dubrava, Croatia (Alegria 2 validation)UK NEQAS Haematology (webinar speaker)TriCore Reference Laboratories (webinar speaker)Memorial Sloan Kettering Cancer Center (webinar speaker)

Quality and Compliance

Sebia implements a strict control and traceability policy across the entire production and distribution chain. All IVD products are CE-marked; the quality management system is certified to ISO 13485:2016 and is MDSAP-compliant.

EvidenceLisses
ISO 13485:2016
MDSAP-compliant
CE marking (IVD products)
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