Definition: Intended For Single Use For Individual Blood Group Determination For Educational And Informational Purposes
| Device Type ID | 2437 |
| Device Name | Self-contained Blood Grouping |
| Physical State | Plastic Card With Mixing Channels And Monoclonal Antibodies |
| Technical Method | The Device Is Self-contained And Consists Of Reagents And Reaction Areas And Requires No Other Accessories With The Exception Of Those Used To Add The Blood Sample To The Device |
| Target Area | Plastic/paper Card, Plate, Slide Or Microtubules With Blood Grouping Antibodies |
| Regulation Description | Automated Blood Grouping And Antibody Test System. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9175 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OQX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |