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510(k) Data Aggregation
K Number
K212113Device Name
MagXtract Collection Tube
Manufacturer
MagBio Genomics, Inc.
Date Cleared
2022-07-28
(386 days)
Product Code
QBD
Regulation Number
866.2950Why did this record match?
Applicant Name (Manufacturer) :
MagBio Genomics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MagXtract Collection Tube is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS-COV-2 virus RNA. These devices can be used for collection transport and storage of specimens at refrigerated (2-8℃) or ambient temperatures (20-25℃). Specimens collected and stored in a MagXtract collection tube are suitable for use with legally marketed molecular diagnostic devices.
Device Description
The MagXtract collection tube is intended for the collection, transportation, direct lysis, and stabilization of RNA from unprocessed nasopharyngeal swab samples suspected of containing SARS-COV-2. The MagXtract collection tube stores and transports specimens in a closed tube. Proper specimen collection and transport are essential in molecular testing and obtaining accurate test results. MagXtract collection tube allows for the stabilization and transportation of nasopharyngeal swab samples at ambient temperature from the collection site to the processing laboratory. The MagXtract collection tube consists of a sterile plastic, 5 ml cryogenic collection tube pre-filled with 1.2 mL of proprietary stabilization/lysis buffer (MagBio CTL Medium). MagBio CTL Medium is intended to disrupt/lyse cells and stabilize SARS-COV-2. The preserved and stabilized RNA maintains its integrity for downstream molecular based detection/analysis. MagXtract collection tube may be used in conjunction with a swab or as a tube alone.
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