BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Alere Acceava Strep A Rapid Test

    Reg #: 2027969 · FEI: 1000125596 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    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
    K010582

    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
    Antigens, All Groups, Streptococcus Spp. GTY

    Proprietary Names

    Alere Acceava Strep A Rapid Test Clearview Strep A Exact II Dipstick HENRY SCHEIN One Step+ Strep A Dipstick Test Pro Advantage by NDC Strep A Test- Throat Swab McKesson CONSULT Diagnostics Strep A Dipstick Stanbio QuStick Strep A Rapid Test Strip Procedure No. 6000 CLIA Waived Medline Strep A Dipstick Fisher Scientific Sure-Vue Strep A Test Alere Signify Strep A Dipstick Alere Acceava Strep A Cardinal Health Strep A Dipstick Rapid Test Immunostics Inc. Detector Strep A

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility