Viral Transport Medium (VTM) for diagnosis A Viral Transport Medium (VTM) following the WHO and CDC recommendations with or without swabThe success of the diagnosis of SARS-CoV-2 (2019-nCo...View details
Please note that products in product code QBD are not within the scope of the COVID-19 Transport Media Policy. The remainder of the product codes listed above are within the policy’s scope.
Generally, transport media consisting of PBS/saline would be regulated by this regulation.
** Generally, transport media consisting of certain types of viral transport media (VTM) would be regulated by these regulations, with the majority under 21 CFR 866.2390.
*** Generally, transport media consisting of certain types of inactivating transport media (ITM) would be regulated by this regulation.
Q: Which product codes are used for transport medium products?
A: This table shows product codes for different types of transport medium products.
|Classification Regulation||Device Type||Product Code||Device Classification|
|21 CFR 866.2300*||Culture Media, Non-Selective and Non-Differential||JSG||I (Exempt)|
|21 CFR 866.2390**||Culture Media, Non-Propagating Transport||JSM||I (Reserved)|
|Culture Media, Anaerobic Transport||JSL||I (Reserved)|
|Culture Media, Propagating Transport||JSN||I (Reserved)|
|21 CFR 866.2900**||Device, Specimen Collection||LIO||I (Reserved)|
|System, Transport, Aerobic||JTW||I (Reserved)|
|Transport Systems, Anaerobic||JTX||I (Reserved)|
|21 CFR 866.2950***||Microbial Nucleic Acid Storage and Stabilization Device||QBD||II|
Customized flocked swab products: materials can be customized, head size can be customized, mold opening can be customized, color can be customi...View details