| 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 |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.1640
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
