BEUDAMED
    FDA Registration Active 🇺🇸 United States

    clonoSEQ® Assay

    Reg #: 3019895551 · FEI: 3019895551 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ADAPTIVE BIOTECHNOLOGIES
    Registration Number
    3019895551
    FEI Number
    3019895551
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1165 Eastlake Avenue East
    City
    Seattle
    State
    WA
    ZIP
    98109
    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
    Correspondent
    Sakshi Narkhede

    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 Develop Specifications But Do Not Manufacture At This Facility