BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PreciControl LPA Gen.2

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    97
    Establishment Types
    1
    Classifications
    1

    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

    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
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    PreciControl LPA Gen.2 PTH CS G2 Elecsys E2G V2 IGF-1 CC5 Elecsys CalCheck IGFBP-3 Elecsys total PSA CalCheck Total PSA CC 3 Elecsys A2M Serum Control Kit TSH CalCheck 5 Elecsys Prolactin II CalCheck 5 IGFBP-3 CC5 Elecsys Elecsys CalCheck T-Uptake Elecsys PTH CalCheck 5 Elecsys Myoglobin CalCheck 5 Control-Set b2-MICROGLOBULIN PreciControl Maternal Care Elecsys CA 125 II CalCheck Elecsys Troponin I CalCheck 5 Elecsys CK-MB CalCheck 5 Elecsys SHBG CalCheck 5 Elecsys Folate III CalCheck Androstenedione CC5 Elecsys CalCheck Androstenedione Anti-TSHR CC 3 Elecsys TSH CC 5 Elecsys Elecsys N-MID Osteocalcin CalCheck 5 Elecsys HCG STAT CalCheck 5 Elecsys Rubella IgG CalCheck 5 Elecsys CEA CalCheck 5 Elecsys DHEA-S CalCheck 5 Elecsys IgE CalCheck 5 PreciControl Anti-HAV Elecsys Troponin T CalCheck 5 Elecsys Insulin CalCheck 5 PreciControl TS Elecsys Elecsys Digoxin CalCheck 5 PreciControl Toxo IgG PreciControl TS Elecsys Estradiol III CalCheck Elecsys FT4 CalCheck PreciControl Maternal Care Gen.2 Elecsys CA 19-9 CalCheck 5 Elecsys C-Peptide CalCheck 5 Precicontrol Troponin T PreciControl Anti-HAV IgM PCT CC 5 Elecsys PreciControl CMV IgG PreciControl Rubella IgM PreciControl CMV IgM PreciControl HE4 Elecsys CalCheck Testosterone Elecsys LH CalCheck 5 Elecsys Anti-Tg CalCheck Elecsys Progesterone III CalCheck 5 Elecsys CalCheck FT 3 Elecsys T4 CalCheck 5 Elecsys HE4 CalCheck 5 Elecsys T3 CalCheck 5 Syphilis PC Elecsys Elecsys ?-CrossLaps CalCheck Elecsys Vitamin B12 CalCheck Elecsys PCT CalCheck 5 Elecsys Toxo IgG CalCheck 5 Elecsys proBNP II CalCheck 5 Elecsys Vitamin D CalCheck 5 Elecsys TSH CalCheck 5 Elecsys Anti-TPO CalCheck Elecsys ACTH CalCheck CalCheck Vitamin D total III PreciControl Anti-CCP Elecsys Folate RBC CalCheck Elecsys hGH CalCheck 5 PreciControl HSV Elecsys Ferritin CalCheck 5 PreciControl Rubella IgG Elecsys CA 15-3 II CalCheck 5 PreciControl Vitamin D total III Elecsys Anti-CCP CalCheck AFP CalCheck Vitamin D total G3 CC 5 Elecsys Vitamin D total G2 PC Elecsys V2 Troponin T Gen 5 CC 5 Elecsys pTau CC 5 Elecsys AMH CC 5 Elecsys AMH PC Elecsys TG G2 CC 5 Elecsys tTau PC Elecsys tTau CC5 Elecsys ELECSYS ANTI-CCP CALCHECK KIT beta-Amyloid(1-42) G2 PC Elecsys PreciControl ?-Amyloid (1-42) II PTH Elecsys CS V3 beta-Amyloid(1-42) CC 5 Elecsys CalChecks Phospho-Tau (181P) CalChecks ?-Amyloid (1-42) II Precicontrol Total-Tau Toxo IgM PC Elecsys PTH STAT CS Elecsys V3

    Establishment Types

    Manufacture Medical Device