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510(k) K222771

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

K222771 is an FDA 510(k) premarket notification submitted by Hangzhou Bioer Technology Co., Ltd. for the device "Sample Preservative Fluid". The FDA issued a decision of Substantially Equivalent on June 26, 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
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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  • K221547 — InActiv Blue (June 11, 2024)
  • K212878 — Sample preservation solution (April 8, 2024)
  • K231013 — DNA/RNA Shield SafeCollect Saliva Collection kit (September 28, 2023)
  • K221664 — CLEARinse CTS Specimen Collection and Transport System (July 3, 2023)
  • K221802 — iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) (April 3, 2023)
  • K223497 — Spectrum Saliva Collection Device (February 17, 2023)
  • K220059 — Biosci™ Inactivated Transport Medium, Biosci™ ITM (January 19, 2023)

FDA data resources