FDA product code QHT: Reagent Red Blood Cells
QHT is the FDA product code for reagent red blood cells. It is a Unclassified device, regulated under 21 CFR 660.30 and reviewed by the Hematology panel. Devices under QHT reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For the detection of or identification of human blood-group antibodies
Classification
| Field | Value |
|---|---|
| Device name | Reagent Red Blood Cells |
| Device class | Unclassified |
| Regulation | 21 CFR 660.30 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | Contact FDA |
Recalls for QHT devices
openFDA lists no recalls for product code QHT.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A9560 — Technetium tc-99m labeled red blood cells, diagnostic, per study dose, up to 30 millicuries
Frequently asked questions
What is FDA product code QHT?
QHT is the FDA product code for reagent red blood cells. It is a Unclassified device, regulated under 21 CFR 660.30 and reviewed by the Hematology panel.
What device class is QHT?
Unclassified, regulation 21 CFR 660.30. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QHT
- Run a recall and safety report across every QHT manufacturer
- Watch product code QHT 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.