PBC · Manual Blood Grouping And Antibody Test Systems
Hematology · 21 CFR 864.9175 · Class 2
Overview
| Product Code | PBC |
|---|---|
| Device Name | Manual Blood Grouping And Antibody Test Systems |
| Regulation | 21 CFR 864.9175 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
