| Device Type ID | 3503 |
| Device Name | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.1640 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MYI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3503 |
| Device | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Product Code | MYI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| CFR Regulation Number | 866.1640 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANDX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALERE SCARBOROUGH, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |