Device |
system, test, genotypic detection, resistant markers, enterococcus species |
Regulation Description |
Antimicrobial susceptibility test powder. |
Definition |
The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | NIJ |
Premarket Review |
Division of Microbiology Devices
(DMD)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.1640
|
Device Class |
2
|
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 |
|
|