| Device Type ID | 6287 |
| Device Name | Test System, For Drugs Of Abuse |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MGX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6287 |
| Device | Test System, For Drugs Of Abuse |
| Product Code | MGX |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
False Negative Result | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Express Diagnostics Int'l., Inc. | II | Jan-30-2015 |