FDA product code PBC: Manual Blood Grouping And Antibody Test Systems
PBC is the FDA product code for manual blood grouping and antibody test systems. It is a Class II device, regulated under 21 CFR 864.9175 and reviewed by the Hematology panel. Devices under PBC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
Classification
| Field | Value |
|---|---|
| Device name | Manual Blood Grouping And Antibody Test Systems |
| Device class | Class II |
| Regulation | 21 CFR 864.9175 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for PBC devices
openFDA lists no recalls for product code PBC.
Frequently asked questions
What is FDA product code PBC?
PBC is the FDA product code for manual blood grouping and antibody test systems. It is a Class II device, regulated under 21 CFR 864.9175 and reviewed by the Hematology panel.
What device class is PBC?
Class II, regulation 21 CFR 864.9175. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PBC
- Run a recall and safety report across every PBC manufacturer
- Watch product code PBC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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