| Device Type ID | 2473 |
| Device Name | System, Identification, Hepatitis B Antigen |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KSJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2473 |
| Device | System, Identification, Hepatitis B Antigen |
| Product Code | KSJ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
False Positive Result | 94 |
Mechanical Problem | 50 |
False Negative Result | 41 |
Incorrect Or Inadequate Test Results | 25 |
High Test Results | 21 |
Adverse Event Without Identified Device Or Use Problem | 20 |
Low Test Results | 12 |
Missing Value Reason | 4 |
Output Problem | 1 |
Insufficient Information | 1 |
Computer Software Problem | 1 |
Device Issue | 1 |
Tube | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 273 |