| Device Type ID | 3607 |
| Device Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NCD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3607 |
| Device | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
| Product Code | NCD |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
False Positive Result | 12 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 4 |
| Total Device Problems | 16 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Qiagen Sciences LLC | II | Mar-22-2016 |