BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sure-Vue Serum/Urine hCG

    Reg #: 2027969 · FEI: 1000125596 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Alere San Diego, Inc.
    Registration Number
    2027969
    FEI Number
    1000125596
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9942 Mesa Rim Road
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K993065

    Owner / Operator

    Firm Name
    Abbott
    Operator Number
    9006731
    Address
    100 Abbott Park Road, Dept. RX51/J55/MS 6134
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Visual, Pregnancy Hcg, Prescription Use JHI

    Proprietary Names

    Sure-Vue Serum/Urine hCG Pro Advantage by NDC Urine/Serum Pregnancy Cassette Device Beckman Coulter Inc's ICON 25 hCG Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum Henry Schein One Step+ hCG Combo test in Serum or Urine ICON 25 hCG Immunochemical Test for hCG in Urine (CLIA Waived) and Serum

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility