BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Aptio Automation System

    Reg #: 2517506 · FEI: 2517506 · Expires 2025
    View on FDA
    Products
    76
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    76

    Registration Details

    Registration Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Registration Number
    2517506
    FEI Number
    2517506
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 GBC DR, PO Box 6101
    City
    NEWARK
    State
    DE
    ZIP
    19714
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043546

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US
    Correspondent
    Mary Seeger

    Products

    Device Name Product Code
    Radioimmunoassay (Two-Site Solid Phase), Ferritin JMG
    Enzymatic Method, Ammonia JIF
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Valproic Acid LEG
    Enzyme Immunoassay, Phenobarbital DLZ
    Enzyme Immunoassay, Amphetamine DKZ
    Ferrozine (Colorimetric) Iron Binding Capacity JMO
    Enzyme Immunoassay, Carbamazepine KLT
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Procainamide LAR
    Complement C3, Antigen, Antiserum, Control CZW
    Test Reagents For Ethyl Alcohol DMJ
    Enzymatic, Carbon-Dioxide KHS
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Immunoassay Method, Troponin Subunit MMI
    Electrode, Ion-Specific, Chloride CGZ
    Radioimmunoassay, Vancomycin LEH
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Acid Phosphatase, Thymolphthale Inmonophosphate CKE
    Enzyme Immunoassay, Barbiturate DIS
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Colorimetric Method, Lipoproteins JHM
    Colorimetry, Acetaminophen LDP
    Enzyme Immunoassay, Theophylline KLS
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Bromcresol Purple Dye-Binding, Albumin CJW
    Electrode, Ion Specific, Potassium CEM
    Acid, Uric, Uricase (Oxygen Rate) JHC
    Radioassay, Triiodothyronine Uptake KHQ
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Enzyme Immunoassay, Methadone DJR
    Flame Photometry, Lithium JIH
    Radioimmunoassay, Free Thyroxine CEC
    Enzyme Immunoassay, N-Acetylprocainamide LAN
    Enzyme Immunoassay, Benzodiazepine JXM
    Colorimetry, Cholinesterase DIH
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Diphenylhydantoin DIP
    Test, Natriuretic Peptide NBC
    System, Test, C-Reactive Protein DCN
    Complement C4, Antigen, Antiserum, Control DBI
    Enzyme Immunoassay, Lidocaine KLR
    Ph Rate Measurement, Carbon-Dioxide JFL
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Catalytic Methods, Amylase JFJ
    Biuret (Colorimetric), Total Protein CEK
    Colorimetric Method, Cpk Or Isoenzymes JHY
    Colorimetry, Salicylate DKJ
    Cyclosporine MKW
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Enzyme Immunoassay, Gentamicin LCD
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Myoglobin, Antigen, Antiserum, Control DDR
    Hexokinase, Glucose CFR
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    System, Test, Low Density, Lipoprotein MRR
    Photometric Method, Magnesium JGJ
    Diazo Colorimetry, Bilirubin CIG
    Radioimmunoassay, Immunoglobulins (G, A, M) CFQ
    Transferrin, Antigen, Antiserum, Control DDG
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Assay, Glycosylated Hemoglobin LCP
    Acid, Lactic, Enzymatic Method KHP
    Chromatographic Separation, Cpk Isoenzymes JHT
    Albumin, Antigen, Antiserum, Control DCF
    Enzyme Immunoassay, Digoxin KXT
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    System, Test, Human Chorionic Gonadotropin DHA
    Enzyme Immunoassay, Digitoxin LFM
    Cresolphthalein Complexone, Calcium CIC
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Radioimmunoassay, Tobramycin KLB

    Proprietary Names

    Aptio Automation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility