BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Flowflex Plus COVID-19 + Flu A/B Home Test

    DI: 00810107290002 · Model: L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945 · Acon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    27
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Flowflex Plus COVID-19 + Flu A/B Home Test
    Primary DI
    00810107290002
    Version / Model
    L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
    Catalog Number
    L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
    Company Name
    Acon Laboratories, Inc.
    Labeler DUNS
    781100966
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-30
    Public Version
    1
    Public Version Date
    2026-02-09
    Public Version Status
    New
    Public Device Record Key
    f9181d34-90db-4d8f-b536-b5aaab275686

    Device Description

    1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L03A-R0845): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L03A-R0945): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    SCA Multi-analyte respiratory virus antigen detection test

    GMDN Terms

    Code Name
    66040 Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

    Identifiers

    Type ID
    Package 00810107290033
    Primary 00810107290002
    Package 60810107290028
    Package 00810107290026
    Package 70810107290032
    Package 60810107290035
    Package 10810107290023
    Package 00810107290019
    Package 20810107290013
    Package 10810107290016
    Package 80810107290015
    Package 20810107290020
    Package 30810107290034
    Package 50810107290014
    Package 40810107290017
    Package 20810107290037
    Package 10810107290030
    Package 40810107290024
    Package 60810107290011
    Package 00810107290040
    Package 30810107290041
    Package 50810107290021
    Package 30810107290027
    Package 80810107290039
    Package 30810107290010
    Package 40810107290031
    Package 50810107290038

    Customer Contacts

    Phone
    +1(800)838-9502 ext. 1
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.