| Device |
system,test,genotypic detection,resistant markers,staphylococcus colonies |
| Regulation Description |
Antimicrobial susceptibility test powder. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | MYI |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.1640
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococcus aureus (MRSA) for Culture Based Devices
|
|
| Third Party Review |
Not Third Party Eligible |
|
|
