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510(k) K210440

Disposable Sampler Inactivated Transport Media, Nest ITM by Wuxi Nest Biotechnology Co., Ltd. — Product Code QBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2021
Date Received
February 12, 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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