| Device Type ID | 3351 |
| Device Name | Kit, Fastidious Organisms |
| 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 | JST |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3351 |
| Device | Kit, Fastidious Organisms |
| Product Code | JST |
| 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 | 16 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 7 |
| Total Device Problems | 23 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioMerieux SA | II | Jun-12-2018 |
| 2 | Biomerieux Inc | II | Aug-17-2018 |
| 3 | Biomerieux Inc | II | May-22-2017 |