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510(k) K202641

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

K202641 is an FDA 510(k) premarket notification submitted by Zymo Research for the device "DNA/RNA Shield Collection Tube". The FDA issued a decision of Substantially Equivalent on December 14, 2020. The device falls under product code QBD (Microbial Nucleic Acid Storage And Stabilization Device), a Class II device regulated under 21 CFR 866.2950. Zymo Research has at least 1 other 510(k) clearance on record.

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.

Other clearances by Zymo Research

  • K231013 — DNA/RNA Shield SafeCollect Saliva Collection kit (September 28, 2023)

Other clearances for product code QBD

  • K242820 — Puritan PurSafe Plus Collection and Transport System (May 27, 2025)
  • K240797 — PPH Saliva Collection Kit (October 11, 2024)
  • K222771 — Sample Preservative Fluid (June 26, 2024)
  • K233324 — Molecular Transport Media - MTM (June 17, 2024)
  • 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)

FDA data resources