Definition: A Manual Blood Grouping And Antibody Test System Is Used To Group Red Blood Cells And To Detect Antibodies To Blood Group Antigens.
| Device Type ID | 2442 |
| Device Name | Manual Blood Grouping And Antibody Test Systems |
| Physical State | Solid |
| Technical Method | Manual |
| Target Area | IVD |
| 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 | PBC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2442 |
| Device | Manual Blood Grouping And Antibody Test Systems |
| Product Code | PBC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Blood Grouping And Antibody Test System. |
| CFR Regulation Number | 864.9175 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIO-RAD MEDICAL DIAGNOSTICS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
False Negative Result | 1 |
| Total Device Problems | 1 |