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510(k) K212113

MagXtract Collection Tube by Magbio Genomics, Inc. — Product Code QBD

K212113 is an FDA 510(k) premarket notification submitted by Magbio Genomics, Inc. for the device "MagXtract Collection Tube". The FDA issued a decision of Substantially Equivalent on July 28, 2022. The device falls under product code QBD (Microbial Nucleic Acid Storage And Stabilization Device), a Class II device regulated under 21 CFR 866.2950.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2022
Date Received
July 7, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microbial Nucleic Acid Storage And Stabilization Device
Device Class
Class II
Regulation Number
866.2950
Review Panel
MI
Submission Type

Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.

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FDA data resources