| Device Type ID | 3438 |
| Device Name | Gram Positive Identification Panel |
| 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 | LQL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3438 |
| Device | Gram Positive Identification Panel |
| Product Code | LQL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Microorganism Differentiation And Identification Device. |
| CFR Regulation Number | 866.2660 [🔎] |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 118 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 89 |
Fluid Leak | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 209 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioMerieux SA | II | Jun-12-2018 |
| 2 | Biomerieux Inc | II | Oct-11-2018 |
| 3 | Biomerieux Inc | II | Sep-18-2017 |
| 4 | Biomerieux Inc | II | May-22-2017 |