BEUDAMED
    FDA Registration Active 🇺🇸 United States

    clonoSEQ® Assay

    Reg #: 3009879426 · FEI: 3009879426 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ADAPTIVE BIOTECHNOLOGIES
    Registration Number
    3009879426
    FEI Number
    3009879426
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    19910 N Creek Parkway S
    City
    Bothell
    State
    WA
    ZIP
    98011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200009

    Owner / Operator

    Firm Name
    Adaptive Biotechnologies
    Operator Number
    10059613
    Address
    1165 Eastlake Avenue East
    City
    Seattle
    State
    WA
    Postal Code
    98109
    Country
    US

    Products

    Device Name Product Code
    Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies QDC

    Proprietary Names

    clonoSEQ® Assay

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device