510(k) K242820

Puritan PurSafe Plus Collection and Transport System by Puritan Medical Products, LLC — Product Code QBD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 27, 2025
Date Received: September 18, 2024
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 Puritan Medical Products, LLC

K162284 — Puritan Fecal Opti-Swab Collection and Transport System (November 4, 2016)
K160082 — Puritan Opti-Tranz Cary-Blair Collection and Transport System (July 29, 2016)
K142366 — Puritan OptiTranz Liquid Stuart Collection and Transport System (January 9, 2015)
K131630 — PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (October 21, 2013)
K120846 — TRANSPORT CULTURE MEDIUM DEVICE (June 8, 2012)
K113249 — TRANSPORT CULTURE MEDIUM DEVICE (March 1, 2012)

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