| Device Type ID | 3350 |
| Device Name | Kit, Identification, Enterobacteriaceae |
| 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 | JSS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3350 |
| Device | Kit, Identification, Enterobacteriaceae |
| Product Code | JSS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Microorganism Differentiation And Identification Device. |
| CFR Regulation Number | 866.2660 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
METASYSTEMS INDIGO GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 4 |
Incorrect Or Inadequate Test Results | 3 |
| Total Device Problems | 7 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AdvanDx, Inc. | III | Jan-02-2014 |
| 2 | Becton Dickinson & Co. | III | Jul-11-2014 |