| Device Type ID | 3403 |
| Device Name | Device, General Purpose, Microbiology, Diagnostic |
| 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 | LIB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3403 |
| Device | Device, General Purpose, Microbiology, Diagnostic |
| Product Code | LIB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Microorganism Differentiation And Identification Device. |
| CFR Regulation Number | 866.2660 [🔎] |
| Device Problems | |
|---|---|
False Negative Result | 2 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioMerieux SA | II | Feb-04-2016 |
| 2 | BioMerieux SA | II | Apr-18-2014 |
| 3 | Biomerieux Inc | II | Mar-12-2014 |
| 4 | Remel Inc | II | Dec-16-2014 |
| 5 | Remel Inc | II | Apr-18-2014 |