BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MassCheck® Antimycotic Drugs Plasma/EXTENDED Controls, Bi-Level, Level I and Level II

    Reg #: 3003951180 · FEI: 3003951180 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
    Registration Number
    3003951180
    FEI Number
    3003951180
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Am Haag 12
    City
    Gräfelfing Bavaria
    Country
    DE

    Owner / Operator

    Firm Name
    CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH
    Operator Number
    9067715
    Address
    Am Haag 12, --
    City
    Graefelfing
    State
    DE-NOTA
    Postal Code
    82166
    Country
    DE

    US Agent

    Business Name
    confinis USA Inc.
    Contact Name
    Alfred Lerch
    Address
    600 Park Offices Drive Suite 300, Unit #50
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    910 2289391

    Products

    Device Name Product Code
    Drug Specific Control Materials LAS

    Proprietary Names

    MassCheck® Antimycotic Drugs Plasma/EXTENDED Controls, Bi-Level, Level I and Level II Imatinib, Dasatinib, Nilotinib Plasma Controls, Bi-Level, Level I and Level II MassCheck® Antidepressants 2/ Psychostimulants/EXTENDED Plasma Controls, Bi-Level, Level I and Level II Mycophenolic Acid Plasma Controls, Bi-Level, Level I and Level II Alprazolam, Trazodone Plasma Controls, Bi-Level (I+II) Clobazam, Norclobazam Plasma Controls, Bi-Level (I+II) Itraconazole, Posaconazole, Voriconazole Plasma Controls, Tri-Level, Level I, Level II and Level III Trileptal®, Zonisamide Serum Controls, Bi-Level (I+II) Rufinamide, Felbamate, Lacosamide Serum Controls, Bi-Level (I+II) MassCheck® Mycophenolic Acid/Glucuronide Plasma Controls, Bi-Level, Level I and Level II Extended Benzodiazepines Plasma Controls, Bi-Level, Level I and Level II Antiepileptic Drugs Serum Controls, Bi-Level, Tri-Level, Level I, Level II and Level III MassCheck® Drugs of Abuse Testing Urine Hydrolysis Conrol Set Urine Screening Standard Set MassTox® Drugs of Abuse Testing in urine Sultiame, Lamotrigine Serum Controls, Bi-Level (I+II) Perazine, Quetiapine, Citalopram Plasma Controls, Bi-Level, Level I and Level II MassCheck® Anti-HIV Drugs Plasma Controls, Bi-Level, Level I and Level II MassCheck® Neuroleptics 2/EXTENDED Plasma Controls, Bi-Level, Level I and Level II MassCheck® Benzodiazepines 2 Plasma Controls, Bi-Level, Level I and Level II MassCheck® Tricyclic Antidepressants TCA 2 Plasma Controls, Bi-Level, Level I and Level II MassCheck® Antiarrythmic Drugs Plasma Controls, Bi-Level, Level I and Level II MassCheck® Benzodiazepines 1 Plasma Controls, Bi-Level, Level I and Level II MassCheck® Antiepileptic Drugs/EXTENDED Plasma Controls, Bi-Level, Level I and Level II MassCheck® Antidepressants 1/EXTENDED Plasma Controls, Bi-Level, Level I and Level II Pregabalin, Vigabatrin, Gabapentin Serum Controls, Bi-Level (I+II) Amiodarone, Desethylamiodarone Plasma Controls, Level I and Level II Levetiracetam (Keppra®) Serum Controls, Bi-Level, Level I and Level II MassCheck® Immunosuppressants Whole Blood Controls, Four-Level, Level I, Level II, Level III, Level IV and Blank Control Olanzapine, Desmethylolanzapine Plasma Controls, Bi-Level, Level I and Level II MassCheck® Drugs of Abuse Testing Urine Control Set Level III MassCheck® Tricyclic Antidepressants TCA 1 Plasma Controls, Bi-Level, Level I and Level II MassCheck® Drugs of Abuse Testing Urine Control Set Level II MassCheck® Drugs of Abuse Testing Urine Control Set Level I MassCheck® Neuroleptics 2/EXTENDED2 Plasma Controls, Bi-Level, Level I and Level II

    Establishment Types

    Manufacture Medical Device