| Device Type ID | 3362 |
| Device Name | Discs, Strips And Reagents, Microorganism Differentiation |
| Regulation Description | Microorganism Differentiation And Identification Device. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.2660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JTO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3362 |
| Device | Discs, Strips And Reagents, Microorganism Differentiation |
| Product Code | JTO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Microorganism Differentiation And Identification Device. |
| CFR Regulation Number | 866.2660 [🔎] |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 96 |
Incorrect Or Inadequate Test Results | 46 |
Appropriate Term/Code Not Available | 4 |
False Positive Result | 2 |
Low Readings | 1 |
Fluid Leak | 1 |
Unable To Obtain Readings | 1 |
False Negative Result | 1 |
| Total Device Problems | 152 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioMerieux SA | II | Jun-12-2018 |