BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    COBAS INTEGRA SYSTEM

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    62
    Proprietary Names
    40
    Establishment Types
    2
    Classifications
    62

    Registration Details

    Registration Name
    ROCHE DIAGNOSTICS GMBH
    Registration Number
    9610126
    FEI Number
    3002806559
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SANDHOFER STRASSE 116
    City
    MANNHEIM Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K951595

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US

    US Agent

    Business Name
    Roche Diagnostics Operations Inc
    Contact Name
    Brian Frazier
    Address
    9115 Hague Rd
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    317 5214603

    Products

    Device Name Product Code
    Bromcresol Green Dye-Binding, Albumin CIX
    Lipoprotein X, Antigen, Antiserum, Control DEL
    Fluorescence Polarization Immunoassay, Carbamazepine LGI
    Enzyme Immunoassay, Cocaine JXO
    Diazo Colorimetry, Bilirubin CIG
    Iga, Antigen, Antiserum, Control CZP
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Enzyme Immunoassay, Amphetamine DKZ
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Fluorescence Polarization Immunoassay, Theophylline LGS
    Photometric Method, Iron (Non-Heme) JIY
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Cannabinoids LDJ
    Calibrators, Drug Mixture DKB
    Transferrin, Antigen, Antiserum, Control DDG
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Olive Oil Emulsion (Turbidimetric), Lipase CET
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Assay, Glycosylated Hemoglobin LCP
    Enzyme Immunoassay, Phencyclidine LCM
    Complement C4, Antigen, Antiserum, Control DBI
    System, Test, C-Reactive Protein DCN
    Hexokinase, Glucose CFR
    Enzyme Immunoassay, Benzodiazepine JXM
    System, Test, Urinary Methylmalonic Acid LPT
    Turbidimetric Method, Lipoproteins JHN
    Biuret (Colorimetric), Total Protein CEK
    Enzyme Immunoassay, Quinidine LBZ
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Fluorescence Polarization Immunoassay, Phenobarbital LGQ
    Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) MOJ
    Drug Mixture Control Materials DIF
    Calibrator, Multi-Analyte Mixture JIX
    Colorimetry, Cholinesterase DIH
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Electrode, Ion-Specific, Chloride CGZ
    Nephelometer JZW
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Calibrators, Drug Specific DLJ
    Enzyme Immunoassay, Phenobarbital DLZ
    Catalytic Methods, Amylase JFJ
    Differential Rate Kinetic Method, Cpk Or Isoenzymes JHS
    Cresolphthalein Complexone, Calcium CIC
    Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Enzyme Immunoassay, Valproic Acid LEG
    Enzyme Immunoassay, Digoxin KXT
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Enzyme Immunoassay, Methadone DJR
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Igg, Antigen, Antiserum, Control DEW
    Complement C3, Antigen, Antiserum, Control CZW
    Radioassay, Triiodothyronine Uptake KHQ
    Photometric Method, Magnesium JGJ
    Drug Specific Control Materials LAS
    Enzyme Immunoassay, Barbiturate DIS
    Method, Nephelometric, Immunoglobulins (G, A, M) CFN
    Electrode, Ion Specific, Sodium JGS
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Enzyme Immunoassay, Procainamide LAR
    Enzyme Immunoassay, N-Acetylprocainamide LAN

    Proprietary Names

    COBAS INTEGRA SYSTEM COBAS INTEGRA ANALYZER PRODUCTS TP Gen.2, 300Tests, cobas c, Integra cobas TDM T4 CALIBRATOR KIT cobas INTEGRA ALANINE TRANSAMINASE 500 cobas C INTEGRA FRUC cobas INTEGRA 400 Plus cobas INTEGRA T-UPTAKE 200 THEO, 225Tests, cobas Integra PHNO, 200Tests, cobas Integra I BARBITURATES 200 cobas C ASTL/PYP cobas INTEGRA IRON 2 cobas Integra 400 Plus I PHENCYCLIDINE 200 cobas INTEGRA CANNABINOIDS GEN II FRUC, 250Tests, cobas c 701 cobas INTEGRA ASPARTATE TRANSAMINASE 500 cobas THEOPHYLLINE/100 ETOH2, 150T, cobas c 503 cobas c 70X Total Protein/700 CREAJ Gen.2, 1500Test, cobas c701 cobas c 70X Phosphorus/600 CARB, 200Tests, cobas Integra Ethanol Gen.2 cobas c 70X Iron/750 Creatinine Jaffe Gen.2 cobas INTEGRA BENZODIAZEPINES 200 PHNY, 200Tests, cobas Integra PHOS Gen.2, 250Tests, cobas c, Integra AST 1100Tests cobas c 701 Iron Gen2. 100T c111 cobas INTEGRA ETOH GEN II Phospor 100T cobas c 111 CREAJ Gen.2, 2500Test, cobas c503 CK-MB 100T c111 FRA, 550T, cobas c 503 ETOH2, 850T, cobas c 503 Fructosamine ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device