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510(k) K202641

DNA/RNA Shield Collection Tube by Zymo Research — Product Code QBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2020
Date Received
September 11, 2020
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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