BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CE VRE-03 VRE Positive (Van B)

    Reg #: 1050138 · FEI: 1050138 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Microbiologics, Inc.
    Registration Number
    1050138
    FEI Number
    1050138
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1040 Manchester St
    City
    LEXINGTON
    State
    KY
    ZIP
    40508
    Country
    US

    Owner / Operator

    Firm Name
    Microbiologics, Inc.
    Operator Number
    10091576
    Address
    200 Cooper Avenue North
    City
    Saint Cloud
    State
    MN
    Postal Code
    56303
    Country
    US
    Correspondent
    Tina Sobania

    Products

    Device Name Product Code
    Kit, Quality Control For Culture Media JTR

    Proprietary Names

    CE VRE-03 VRE Positive (Van B) GBS-01 Group B Strep Positive MSSE-01 MSSE Negative Control MRSA-02 MRSA Negative CE VRE-01 VRE Positive (Van A) GBS-02 Group B Strep Negative URI-KIT CTGC-VP CT/GC Swab Validation Set (Chlamydi/GC) CE VRE-02 VRE Negative URI-KIT Culture Control Kit for Uricult MRSA-01 MRSA Positive

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)