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 Alb Luz, Permantis Public Health and Puritan Medical Products, LLC.
FDA 510(k) Cleared Microbial Nucleic Acid Storage And Stabilization Device Devices (Product Code QBD)
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 - 5 submissions in the last 24 months compared to 8 in the prior period.
FDA Review Time
Recent submissions under QBD have taken an average of 423 days to reach a decision - up from 313 days historically. Manufacturers should account for longer review timelines in current project planning.
QBD devices are reviewed by the Microbiology panel. Browse all Microbiology devices →