510(k) K222771

Sample Preservative Fluid by Hangzhou Bioer Technology Co., Ltd. — Product Code QBD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 26, 2024
Date Received: September 14, 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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