| Device Type ID | 3130 |
| Device Name | Test, Hiv Detection |
| Review Panel | Immunology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MZF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3130 |
| Device | Test, Hiv Detection |
| Product Code | MZF |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
False Positive Result | 574 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 67 |
False Negative Result | 61 |
Low Test Results | 37 |
Adverse Event Without Identified Device Or Use Problem | 33 |
High Test Results | 16 |
Calibration Error | 13 |
Incorrect Or Inadequate Test Results | 12 |
No Apparent Adverse Event | 8 |
Non Reproducible Results | 4 |
Appropriate Term/Code Not Available | 1 |
Failure To Calibrate | 1 |
Washer | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Low Readings | 1 |
Mechanical Problem | 1 |
Leak / Splash | 1 |
Human Factors Issue | 1 |
| Total Device Problems | 833 |