BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R-Biopharm Clinical USA Inc.

    Reg #: 3016548670 · FEI: 3016548670 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    R-Biopharm Clinical USA Inc.
    Registration Number
    3016548670
    FEI Number
    3016548670
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    870 Vossbrink Dr
    City
    Washington
    State
    MO
    ZIP
    63090
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171511

    Owner / Operator

    Firm Name
    R-Biopharm Clinical USA Inc.
    Operator Number
    10088745
    Address
    870 Vossbrink Drive
    City
    Washington
    State
    MO
    Postal Code
    63090
    Country
    US

    Products

    Device Name Product Code
    Reagents For Detection Of Norovirus Nucleic Acid PIQ
    Real Time Nucleic Acid Amplification System OOI
    Norovirus Serological Reagent OUC
    Protein, Complement, Antigen, Antiserum, Control DHL
    P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin JNN

    Proprietary Names

    RIDA®GENE Norovirus GI/GII RIDA® CCD-Inhibitor RIDASCREEN® Pancreatic Elastase ELISA

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198