BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Labcorp CLS

    Reg #: 3006285950 · FEI: 3004552864 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Labcorp CLS
    Registration Number
    3006285950
    FEI Number
    3004552864
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    8211 SciCor Drive
    City
    Indianapolis
    State
    IN
    ZIP
    46214
    Country
    US

    Regulatory Submissions

    510(k) Number
    K960250

    Owner / Operator

    Firm Name
    Labcorp CLS
    Operator Number
    10029208
    Address
    8211 SciCor Drive
    City
    Indianapolis
    State
    IN
    Postal Code
    46214
    Country
    US
    Correspondent
    Isabelle Le Moigne

    Products

    Device Name Product Code
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA

    Proprietary Names

    Greiner Sarstedt Terumo Becton Dickinson Nunc Starplex Scientific Qiagen Myriad RBM SAMCO Nalgene Corning Streck Sigma Aldrich Fisher Scientific Simport Kendal

    Establishment Types

    Repack or Relabel Medical Device