BEUDAMED
    FDA Registration Active 🇫🇷 France

    SEBIA

    Reg #: 8023024 · FEI: 6387 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    46
    Establishment Types
    1
    Classifications
    28

    Registration Details

    Registration Name
    SEBIA
    Registration Number
    8023024
    FEI Number
    6387
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PARC TECHNOLOGIQUE LEONARD DE VINCI
    City
    EVRY Essonne
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K171861

    Owner / Operator

    Firm Name
    SEBIA
    Operator Number
    8023024
    Address
    PARC TECHNOLOGIQUE LEONARD DE, 27 rue Leonard de VINCI
    City
    Lisses-Evry
    State
    FR-NOTA
    Postal Code
    91008
    Country
    FR
    Correspondent
    Arnaud - Collin

    US Agent

    Business Name
    Sebia
    Contact Name
    Karen A Anderson
    Address
    1705 Corporate Drive, Suite 400
    City
    Norcross
    State
    GA
    ZIP
    30093
    Country
    US
    Email
    [email protected]
    Phone
    404 7881059

    Products

    Device Name Product Code
    Hemoglobin A1c Test System PDJ
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Test, Carbohydrate Deficient Transferrin NAO
    Densitometeric, Protein Fractionation JQJ
    Kappa, Antigen, Antiserum, Control DFH
    Lambda, Antigen, Antiserum, Control DEH
    Immunoelectrophoretic, Immunoglobulins, (G, A, M) CFF
    Electrophoretic, Protein Fractionation CEF
    Immunochemical, Bence-Jones Protein JKM
    Abnormal Hemoglobin Quantitation GKA
    Control, Hemoglobin, Abnormal JCM
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Electrophoretic, Lactate Dehydrogenase Isoenzymes CFE
    Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica JQT
    Electrophoretic Separation, Alkaline Phosphatase Isoenzymes CIN
    Colorimetric Method, Cpk Or Isoenzymes JHY
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Hemoglobin S GIQ
    Assay, Fetal Hemoglobin KQI
    System, Analysis, Electrophoretic Hemoglobin JBD
    Hemoglobin C (Abnormal Hemoglobin Variant) MLL
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Assay, Glycosylated Hemoglobin LCP
    Calibrator, Primary JIS
    Alpha-1-Antitrypsin Kit, Qualitative Phenotype OBZ
    Apparatus, Electrophoresis, For Clinical Use JJN
    Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl LBT
    Electrophoretic Separation, Lipoproteins JHO

    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 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 HYDRASYS Minicap Hemoglobin HYDRAGEL ISO-PAL Normal Control Serum Hypergamma Control Serum FLC Kappa FLC Lambda FLC Control 1 FLC Control 2 HYDRAGEL ISO-LDH Minicap Immunotyping CAPI 3 NEONAT HB USING THE CAPILLARYS 3 DBS INSTRUMENT HYDRAGEL LDL/HDL CHOL Direct HYDRAGEL LIPOPROTEIN(E)

    Establishment Types

    Manufacture Medical Device