BEUDAMED
    FDA Registration Active 🇺🇸 United States

    nAbCyte Anti-AAVRh74var HB-FE Assay

    Reg #: 3005415780 · FEI: 3005415780 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Monogram Biosciences-Labcorp
    Registration Number
    3005415780
    FEI Number
    3005415780
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    347 Oyster Point Blvd.
    City
    S San Fran
    State
    CA
    ZIP
    94080
    Country
    US

    Regulatory Submissions

    PMA Number
    H230005

    Owner / Operator

    Firm Name
    Laboratory Corporation of America Holdings
    Operator Number
    10049571
    Address
    100 Perimeter Park, Suite C
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US

    Products

    Device Name Product Code
    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors QWQ

    Proprietary Names

    nAbCyte Anti-AAVRh74var HB-FE Assay

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device