FDA Product Code QBD: Microbial Nucleic Acid Storage And Stabilization Device
Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material.
Leading manufacturers include Zymo Research, Magbio Genomics, Inc. and Zhejiang Gene Science Co., Ltd..
17
Total
16
Cleared
345d
Avg days
2018
Since
Declining activity -
2 submissions in the last 2 years
vs 11 in the prior period
Review times improving: avg
227d
recently vs 361d historically
FDA 510(k) Cleared Microbial Nucleic Acid Storage And Stabilization Device Devices (Product Code QBD)
17 devices
Cleared
May 27, 2025
Puritan PurSafe Plus Collection and Transport System
Puritan Medical Products, LLC
Microbiology
251d
Cleared
Oct 11, 2024
PPH Saliva Collection Kit
Permantis Public Health
Microbiology
203d
Cleared
Jun 26, 2024
Sample Preservative Fluid
Hangzhou Bioer Technology Co., Ltd.
Microbiology
651d
Cleared
Jun 17, 2024
Molecular Transport Media - MTM
Alb Luz
Microbiology
262d
Cleared
Jun 11, 2024
InActiv Blue
Fertipro NV
Microbiology
746d
Cleared
Apr 08, 2024
Sample preservation solution
Zhejiang Gene Science Co., Ltd.
Microbiology
942d
Cleared
Sep 28, 2023
DNA/RNA Shield SafeCollect Saliva Collection kit
Zymo Research
Microbiology
171d
Cleared
Jul 03, 2023
CLEARinse CTS Specimen Collection and Transport System
Aardvark Medical, Inc.
Microbiology
390d
Cleared
Apr 03, 2023
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
Mawi Dna Technologies
Microbiology
286d
Cleared
Feb 17, 2023
Spectrum Saliva Collection Device
Spectrum Solutions, LLC
Microbiology
88d
Cleared
Jan 19, 2023
Biosci™ Inactivated Transport Medium, Biosci™ ITM
Shenzhen Dakewe Bio-Engineering Co., Ltd.
Microbiology
374d
Cleared
Aug 08, 2022
Dasky Disposable Sampling Tube (Model name: VSM02)
Ningbo Dasky Life Science Co., Ltd.
Microbiology
433d
Cleared
Jul 28, 2022
MagXtract Collection Tube
Magbio Genomics, Inc.
Microbiology
386d
Cleared
Sep 20, 2021
Disposable Sampler Inactivated Transport Media, Nest ITM
Wuxi Nest Biotechnology Co., Ltd.
Microbiology
220d
Cleared
Dec 14, 2020
DNA/RNA Shield Collection Tube
Zymo Research
Microbiology
94d
Cleared
Sep 17, 2020
eNAT molecular collection and preservation medium
Copan Italia Spa
Microbiology
73d
Not Cleared
Mar 19, 2018
PrimeStore MTM
Longhorn Vaccines and Diagnostics, LLC
Microbiology
299d
About Product Code QBD - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code QBD since 2018, with 16 receiving FDA clearance (average review time: 345 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 11 in the prior period.
FDA 510(k) Review Time - QBD Product Code
Recent submissions under QBD have taken an average of 227 days to reach a decision - down from 361 days historically, suggesting improved FDA processing for this classification.
QBD devices are reviewed by the Microbiology panel. Browse all Microbiology devices →