BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    COBAS INTEGRA REAGENT CASSETTES

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    27
    Proprietary Names
    37
    Establishment Types
    2
    Classifications
    27

    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
    K954992

    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
    Turbidimetric Method, Lipoproteins JHN
    Radioimmunoassay, Vancomycin LEH
    Enzyme Immunoassay, Valproic Acid LEG
    Albumin, Antigen, Antiserum, Control DCF
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Calibrator, Multi-Analyte Mixture JIX
    Hexokinase, Glucose CFR
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Colorimetry, Salicylate DKJ
    Amikacin Serum Assay KLP
    Radioimmunoassay, Methaqualone KXS
    Enzymatic, Carbon-Dioxide KHS
    Enzyme Immunoassay, Amphetamine DKZ
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Calibrators, Drug Specific DLJ
    Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control LKL
    Photometric Method, Magnesium JGJ
    Photometric Method, Iron (Non-Heme) JIY
    Alpha-1-Antitrypsin, Antigen, Antiserum, Control DEM
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Haptoglobin, Antigen, Antiserum, Control DAD
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) MOJ
    Colorimetry, Acetaminophen LDP
    Enzyme Immunoassay, Propoxyphene JXN
    Drug Mixture Control Materials DIF
    Enzyme Immunoassay, Lidocaine KLR

    Proprietary Names

    COBAS INTEGRA REAGENT CASSETTES Pyridoxalphosphat Cobas C111 cobas C ALTL/PYP cobas Integra FP-F-Phenytoin Control TDM FPHNY CALIBRATOR KIT VALP, 200Tests, cobas Integra Pyridoxalphosphate I PROPOXYPHENE 200 cobas INTEGRA HAPTOGLOBIN cobas Integra FP-Calibrator F-Phenytoin Serumproteins T-Standard ASO, 100Tests, cobas Integra UIBC 300Tests cobas c 701 cobas INTEGRA SALICYLATE 150 ALTL/PYP, 275Tests, cobas c cobas Integra FP-F-Valproinacid Control Serum proteins T-Standard cobas INTEGRA AAGP GEN. II AAGP Gen.2, 100Tests, cobas c, Integra TDM FVALP ACID CAL KIT TDM FVALP ACID CTRL KIT cobas c Integra SALICYLATE 150Tests cobas Integra FP-Calibr. F-Valproinacid HAPT Gen.2, 100Tests, cobas c, Integra LIDO, 200Tests, cobas Integra UIBC, 100Tests, cobas c, Integra COBAS INTEGRA PROPOXYPHENE 200 cobas C (111) PYRIDOXAL PHOSPHATE Salicylate AAGP Gen.2, 150Tests, cobas c 701 SALI, 500T, cobas c 503 Unsaturated Iron-Binding Capacity UIBC, 100T, cobas c 503 Aspartate Aminotransferase acc. to IFCC II Alanine Aminotransferase acc. to IFCC II ALTP2, 800T, cobas c 503 ASTP2, 800T, cobas c 503

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device