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510(k) K212878

Sample preservation solution by Zhejiang Gene Science Co., Ltd. — Product Code QBD

K212878 is an FDA 510(k) premarket notification submitted by Zhejiang Gene Science Co., Ltd. for the device "Sample preservation solution". The FDA issued a decision of Substantially Equivalent on April 8, 2024. 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 8, 2024
Date Received
September 9, 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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  • K221802 — iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) (April 3, 2023)
  • K223497 — Spectrum Saliva Collection Device (February 17, 2023)
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FDA data resources