| Device Type ID | 6286 |
| Device Name | Paraquat Assay |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LTD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6286 |
| Device | Paraquat Assay |
| Product Code | LTD |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Incorrect Or Inadequate Test Results | 1 |
| Total Device Problems | 3 |