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510(k) K201849

eNAT molecular collection and preservation medium by Copan Italia Spa — Product Code QBD

K201849 is an FDA 510(k) premarket notification submitted by Copan Italia Spa for the device "eNAT molecular collection and preservation medium". The FDA issued a decision of Substantially Equivalent on September 17, 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. Copan Italia Spa has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2020
Date Received
July 6, 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 Copan Italia Spa

  • K232565 — UriSponge™ (October 11, 2024)
  • K232357 — Copan Universal Transport Medium (UTM-RT) System (April 25, 2024)
  • K220052 — Copan FecalSwab Collection, Transport and Preservation System (December 16, 2022)
  • K180052 — UriSwab-Urine Collection, Transport and Preservation System (March 23, 2018)
  • K142094 — COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM (April 10, 2015)
  • K972448 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (August 20, 1997)
  • K972449 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (August 20, 1997)

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