| Device Type ID | 3605 |
| Device Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Review Panel | Microbiology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MZO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3605 |
| Device | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Product Code | MZO |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
False Negative Result | 130 |
Adverse Event Without Identified Device Or Use Problem | 101 |
Low Test Results | 56 |
No Apparent Adverse Event | 18 |
False Positive Result | 16 |
Incorrect Or Inadequate Test Results | 15 |
Mechanical Problem | 12 |
High Test Results | 5 |
Insufficient Information | 2 |
Missing Value Reason | 1 |
Leak / Splash | 1 |
Low Readings | 1 |
| Total Device Problems | 358 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ORTHO-CLINICAL DIAGNOSTICS | II | Sep-19-2014 |
| 2 | OraSure Technologies, Inc. | III | Apr-18-2016 |