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510(k) Data Aggregation
K Number
K212743Device 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
866.2390Why 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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