BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    BIOKIT S.A.

    Reg #: 9610746 · FEI: 3002806557 · Expires 2026
    View on FDA
    Products
    40
    Proprietary Names
    135
    Establishment Types
    5
    Classifications
    40

    Registration Details

    Registration Name
    BIOKIT S.A.
    Registration Number
    9610746
    FEI Number
    3002806557
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    AV. CAN MONTCAU 7
    City
    LLISSA D AMUNT Barcelona
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K910539
    PMA Number
    P200017

    Owner / Operator

    Firm Name
    BIOKIT S.A.
    Operator Number
    8030752
    Address
    AV CAN MONTCAU, 7, --
    City
    LLISSA D'AMUNT, BARCELONA
    State
    ES-B
    Postal Code
    08186
    Country
    ES
    Correspondent
    ANGELS - ROMA

    Products

    Device Name Product Code
    System, Test, Rheumatoid Factor DHR
    Urinary Homocystine (Nonquantitative) Test System LPS
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Ige, Antigen, Antiserum, Control DGC
    Controls For Blood-Gases, (Assayed And Unassayed) JJS
    Alpha-1-Antitrypsin, Antigen, Antiserum, Control DEM
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Enzyme Immunoassay, Digoxin KXT
    Calibrators, Drug Specific DLJ
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Radioimmunoassay, C-Peptides Of Proinsulin JKD
    Plasma, Coagulation Control GGN
    System, Test, Anticardiolipin Immunological MID
    System, Test, Beta-2-Microglobulin Immunological JZG
    Radioimmunoassay, Vancomycin LEH
    Enzyme Controls (Assayed And Unassayed) JJT
    Calibrator, Secondary JIT
    Radioimmunoassay, Parathyroid Hormone CEW
    Test, Qualitative And Quantitative Factor Deficiency GGP
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 MXJ
    Factor Xiii A, S, Antigen, Antiserum, Control DBT
    Ferritin, Antigen, Antiserum, Control DBF
    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) LOM
    Qualitative And Quantitative Hepatitis B Virus Antibody Assays SEI
    Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 MYF
    Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific LGC
    Epstein-Barr Virus, Other LSE
    Test, Antigen, Nuclear, Epstein-Barr Virus LLM
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control LKL
    System, Test, Infectious Mononucleosis KTN
    Calibrator, Multi-Analyte Mixture JIX
    Platelet Factor 4 Radioimmunoassay LCO
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    Calibrator, Primary JIS
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Fluorescence Polarization Immunoassay, Theophylline LGS
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ

    Proprietary Names

    Rheumajet RF HemosIL Homocysteine Controls HemosIL Homocysteine Alinity c Ferritin/IgE/Myoglobin Control Kit Alinity c IgE Calibrators QUANTIA IgE / Ferritin / Myoglobin Control QUANTIA IgE Calibrator QUANTIA IgE Alinity c IgE Reagent Kit Alinity c A1-Antitrypsin Reagent Kit QUANTIA Proteins Control QUANTIA A1-AT QUANTIA Proteins Calibrator HemosIL D-Dimer HS ARCHITECT iDigoxin Calibrators ARCHITECT iDigoxin BIO-FLASH ARCHITECT C-Peptide Alinity i C-Peptide Reagent Kit HemosIL D-Dimer HS 500 Controls QUANTA Flash aCL IgM Controls HemosIL AcuStar Anti-Cardiolipin IgM Controls QUANTA Flash aCL IgG Controls QUANTA Flash aCL IgM HemosIL AcuStar Anti-Cardiolipin IgM HemosIL AcuStar Anti-Cardiolipin IgG Controls HemosIL AcuStar Anti-Cardiolipin IgG QUANTA Flash aCL IgG Alinity c B2-Microglobulin Reagent Kit ARCHITECT iVancomycin Quantia ASO Control I Alinity i Intact PTH Reagent Kit ARCHITECT iPTH Calibrators ARCHITECT iPTH ARCHITECT iPTH Controls HemosIL Von Willebrand Factor Activity ARCHITECT C-Peptide Controls ARCHITECT C-Peptide Calibrators HemosIL AcuStar Anti-B2 Glycoprotein-I IgG QUANTA Flash B2 GP1 IgM Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgM QUANTA Flash B2 GP1 IgG QUANTA Flash B2 GP1 IgM QUANTA Flash B2 GP1 IgG Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls AcuStar HemosIL AcuStar D-Dimer HemosIL AcuStar D-Dimer Controls QUANTIA B2-Microglobulin QUANTIA B2-Microglobulin Calibrator ADVIA Centaur Herpes-1 IgG (HSV1) Atellica IM Herpes-1 IgG (HSV1) HemosIL Factor XIII Lp(a) control Lp(a) calibrators QUANTIA Ferritin QUANTIA Ferritin Calibrator ADVIA Centaur® Anti-HBe2 (aHBe2) assay ADVIA Centaur® Anti-HBe2 Quality Control (aHBe2 QC) Atellica® IM Anti-HBe2 (aHBe2) Atellica® IM Anti-HBe2 Quality Control (aHBe2 QC) Alinity i DHEA-S Calibrators Alinity i Intact PTH Calibrators Alinity i C-Peptide Calibrators Alinity c Lp(a) Calibrators Alinity c B2-Microglobulin Calibrator Alinity c ASO Calibrator ARCHITECT DHEA-S Controls ARCHITECT DHEA-S Calibrators Alinity i HSV-2 IgG Calibrator Alinity i HSV-2 IgG Alinity i HSV-2 IgG Controls HemosIL D-Dimer controls HemosIL Free Protein S HemosIL D-Dimer ADVIA Centaur EBV-EBNA IgG Quality Control ADVIA Centaur EBV-EBNA IgG ADVIA Centaur EBV-VCA IgM Quality Control ADVIA Centaur EBV-VCA IgM HemosIL von Willebrand Factor Antigen Alinity c Proteins Control Kit QUANTA Flash aPL Multi Controls HemosIL CL Multi-Ab Controls Alinity c A-1-AGP Reagent Kit QUANTIA A-1-AGP ADVIA Centaur Herpes-2 IgG (HSV2) Atellica IM Herpes-2 IgG (HSV2) Monogen Alinity i DHEA-S Controls Alinity c Lp(a) Control Kit Alinity i C-Peptide Controls Alinity c ASO Control II Alinity i Intact PTH Controls Alinity c ASO Control I Atellica IM Herpes-2 IgG Quality Control (HSV2 QC) Atellica IM Herpes-1 IgG Quality Control (HSV1 QC) ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control Alinity c Proteins Calibrators HemosIL CL Anti-?2 Glycoprotein-I IgM HemosIL CL Anti-Cardiolipin IgM ARCHITECT iVancomycin Calibrators QUANTA Flash aCL IgA Controls QUANTA Flash B2GP1 IgA QUANTA Flash B2GP1 IgA Controls QUANTA Flash aCL IgA HemosIL HIT - Ab(PF4-H) HemosIL HIT - Ab(PF4-H) Controls HemosIL AcuStar HIT Controls HemosIL AcuStar HIT-IgG (PF4-H) HemosIL D-Dimer HS 500 Quantia Lp(a) Alinity c Lp(a) Reagent Kit HemosIL D-Dimer Controls Quantia ASO Calibrator HemosIL CL HIT-IgG(PF4-H) Alinity i HSV-1 IgG Calibrator Alinity i HSV-1 IgG Controls Alinity i HSV-1 IgG QUANTIA ASO RHEUMAJET ASO Alinity c ASO Reagent Kit HemosIL Von Willebrand Factor Antigen ARCHITECT iTheophylline Calibrators ARCHITECT iTheophylline Alinity i DHEA-S Reagent Kit ARCHITECT DHEA-S Quantia ASO Control II Alinity i SHBG Reagent Kit Alinity i SHBG Calibrators Alinity i SHBG Controls ARCHITECT SHBG Calibrators ARCHITECT SHBG Controls ARCHITECT SHBG

    Establishment Types

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