BEUDAMED
    FDA Registration Active 🇺🇸 United States

    K1201A GenetiSure Dx Postnatal Assay

    Reg #: 3009189893 · FEI: 3009189893 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Agilent Technologies Inc.
    Registration Number
    3009189893
    FEI Number
    3009189893
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1834 State Highway 71 West
    City
    Cedar Creek
    State
    TX
    ZIP
    78612
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163367

    Owner / Operator

    Firm Name
    Agilent Technologies, Inc
    Operator Number
    10038794
    Address
    5301 Stevens Creek Blvd
    City
    Santa Clara
    State
    CA
    Postal Code
    95051
    Country
    US
    Correspondent
    Widad Ghaben

    Products

    Device Name Product Code
    System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection PFX

    Proprietary Names

    K1201A GenetiSure Dx Postnatal Assay K1201-64200 GenetiSure Dx Hybridization Kit K1201-64300 GenetiSure Dx Wash Buffer Set K1201-64400 GenetiSure Dx Cot-1 Human DNA K1201-64100 GenetiSure Dx DNA Labeling Kit

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device