Device |
transport medium, notified per the vtm guidance |
Regulation Description |
Transport culture medium. |
Definition |
Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus per the guidance (Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus). |
Physical State |
Liquid transport medium |
Technical Method |
Transport medium for clinical upper respiratory specimens for viral diagnosis including COVID |
Target Area |
Human clinical specimens |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | QMC |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.2390
|
Device Class |
1
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |