| Device Type ID | 3606 |
| Device Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,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 | MZP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3606 |
| Device | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Product Code | MZP |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Off-Label Use | 2 |
Low Test Results | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
False Positive Result | 1 |
| Total Device Problems | 5 |