| Device Type ID | 709 |
| Device Name | For Export Only - Antigen, Anti-cardiac, Indirect Fluorescent Antibody Test System |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | NUK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 709 |
| Device | For Export Only - Antigen, Anti-cardiac, Indirect Fluorescent Antibody Test System |
| Product Code | NUK |