QBD — Microbial Nucleic Acid Storage And Stabilization Device Class II

FDA Device Classification

Classification Details

Product Code
QBD
Device Class
Class II
Regulation Number
866.2950
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Definition

Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242820puritan medical productsPuritan PurSafe Plus Collection and Transport SystemMay 27, 2025
K240797permantis public healthPPH Saliva Collection KitOctober 11, 2024
K222771hangzhou bioer technology coSample Preservative FluidJune 26, 2024
K233324alb luzMolecular Transport Media - MTMJune 17, 2024
K221547fertiproInActiv BlueJune 11, 2024
K212878zhejiang gene science coSample preservation solutionApril 8, 2024
K231013zymo researchDNA/RNA Shield SafeCollect Saliva Collection kitSeptember 28, 2023
K221664aardvark medicalCLEARinse CTS Specimen Collection and Transport SystemJuly 3, 2023
K221802mawi dna technologiesiSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)April 3, 2023
K223497spectrum solutionsSpectrum Saliva Collection DeviceFebruary 17, 2023
K220059shenzhen dakewe bio-engineering coBiosci™ Inactivated Transport Medium, Biosci™ ITMJanuary 19, 2023
K211675ningbo dasky life science coDasky Disposable Sampling Tube (Model name: VSM02)August 8, 2022
K212113magbio genomicsMagXtract Collection TubeJuly 28, 2022
K210440wuxi nest biotechnology coDisposable Sampler Inactivated Transport Media, Nest ITMSeptember 20, 2021
K202641zymo researchDNA/RNA Shield Collection TubeDecember 14, 2020
K201849copan italiaeNAT molecular collection and preservation mediumSeptember 17, 2020
DEN170029longhorn vaccines and diagnosticsPrimeStore MTMMarch 19, 2018