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510(k) Data Aggregation

    K Number
    K212743
    Device Name
    MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
    Manufacturer
    MedSchenker, Inc.
    Date Cleared
    2023-05-03

    (611 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedSchenker, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is intended for the collection and transport of upper respiratory clinical specimens, contaming respiratory viruses, from the collection site to the testing laboratory. MedSchenker Smart Transport Medium (STM15-A/STM30-A/SCS30-A) System is a culture-based medium that can be processed using standard clinical laboratory operating procedures for the recovery of infectious viral particles.
    Device Description
    The MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System ("MedSchenker STM") aids in the collection and safe transportation of biological samples that will be tested for viruses. MedSchenker Smart Transport Medium (STM15-A/STM30-A/SCS30-A) System provides a universal transport medium for viruses. MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System includes a universal transporting medium that is room temperature stable, which can sustain infectivity of a plurality of clinically important viruses during transit to the testing laboratory. The formulation of the STM includes protein for stabilization, antimicrobial agents to minimize bacterial and fungal contamination, and a buffer to maintain a neutral pH. The MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is provided in labeled, screw-cap tubes designed for transport of the clinical sample. MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is also supplied as a sample collection kit that contains one screw-cap tube of STM-RT (room-temperature stable) medium and a peel pouch that contains a sterile specimen-collection swab.
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