Definition: The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format.
| Device Type ID | 3506 |
| Device Name | Susceptibility Test Plate, Antifungal |
| 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 | NGZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3506 |
| Device | Susceptibility Test Plate, Antifungal |
| Product Code | NGZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antimicrobial Susceptibility Test Powder. |
| CFR Regulation Number | 866.1640 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BIOMERIEUX INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMERIEUX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
THERMO FISHER SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
Trek Diagnostic Systems | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 21 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 14 |
| Total Device Problems | 35 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomerieux Inc | II | May-22-2017 |