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510(k) K221802

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) by Mawi Dna Technologies — Product Code QBD

K221802 is an FDA 510(k) premarket notification submitted by Mawi Dna Technologies for the device "iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)". The FDA issued a decision of Substantially Equivalent on April 3, 2023. 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
April 3, 2023
Date Received
June 21, 2022
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