| Device Type ID | 3604 |
| Device Name | Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm |
| 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 | MYM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3604 |
| Device | Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm |
| Product Code | MYM |
| FDA Device Classification | Class 3 Medical Device |