FDA product code QHR: Blood Grouping Reagent
QHR is the FDA product code for blood grouping reagent. It is a Unclassified device, regulated under 21 CFR 660.20 and reviewed by the Hematology panel. Devices under QHR reach the market by Contact FDA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for QHR devices, 1 initiated in the last five years.
Definition
For red blood cell antigen typing
Classification
| Field | Value |
|---|---|
| Device name | Blood Grouping Reagent |
| Device class | Unclassified |
| Regulation | 21 CFR 660.20 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | Contact FDA |
Recalls for QHR devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code QHR?
QHR is the FDA product code for blood grouping reagent. It is a Unclassified device, regulated under 21 CFR 660.20 and reviewed by the Hematology panel.
What device class is QHR?
Unclassified, regulation 21 CFR 660.20. Typical premarket route: Contact FDA.
Have QHR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code QHR
- Run a recall and safety report across every QHR manufacturer
- Watch product code QHR 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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