| Device Type ID | 3341 |
| Device Name | Culture Media, Selective And Differential |
| Regulation Description | Selective Culture Medium. |
| 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 | 866.2360 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JSI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3341 |
| Device | Culture Media, Selective And Differential |
| Product Code | JSI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Selective Culture Medium. |
| CFR Regulation Number | 866.2360 [🔎] |
| Device Problems | |
|---|---|
False Negative Result | 5 |
Incorrect Or Inadequate Test Results | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Insufficient Information | 1 |
Material Disintegration | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Acumedia Manufacturers, Inc. | III | Oct-26-2018 |
| 2 | Acumedia Manufacturers, Inc. | II | Jun-14-2017 |
| 3 | Acumedia Manufacturers, Inc. | III | Jun-02-2017 |
| 4 | Becton Dickinson & Co. | II | Apr-22-2016 |
| 5 | Becton Dickinson & Co. | II | Jan-14-2015 |
| 6 | Hardy Diagnostics | II | Apr-14-2015 |
| 7 | Northeast Laboratory Services, Inc. | II | Apr-01-2016 |