BEUDAMED
    Product Code: SAN FDA class 2 21 CFR 866.1650

    Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

    Microbiology

    An automated antimicrobial susceptibility test system for positive blood culture samples is an automated in vitro diagnostic system that performs antimicrobial susceptibility testing directly using positive blood culture specimens, enabling faster pathogen characterization and informed antibiotic therapy decisions for bloodstream infections. It is classified as FDA Class II (510(k) required) under regulation 866.1650 in the Microbiology specialty, with product code SAN. The device is not an implant and does not support life-sustaining functions.

    View on FDA
    510(k)s
    6
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    4
    Years Active
    2

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    Basic Information

    Product Code
    SAN
    Device Class
    FDA class 2
    Regulation Number
    866.1650
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Automated system that performs antimicrobial susceptibility testing using positive blood culture samples

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K253573 ASTar BC G- Kit
    K251875 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
    K241324 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
    K230675 VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
    K221688 ASTar BC G- Kit and ASTar Instrument
    K211815 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.