BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system

    Reg #: 3025772277 · FEI: 3025772277 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    AFFINITY BIOSENSORS
    Registration Number
    3025772277
    FEI Number
    3025772277
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    222 E Canon Perdido St Ste 101
    City
    Santa Barbara
    State
    CA
    ZIP
    93101
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211815

    Owner / Operator

    Firm Name
    Affinity Biosensors
    Operator Number
    10091217
    Address
    222 E Canon Perdido Street, Suite 101
    City
    Santa Barbara
    State
    CA
    Postal Code
    93101
    Country
    US
    Correspondent
    Ken Babcock

    Products

    Device Name Product Code
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation LON
    Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples SAN

    Proprietary Names

    LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility