FDA product code QHS: Anti-Human Globulin
QHS is the FDA product code for anti-human globulin. It is a Unclassified device, regulated under 21 CFR 660.50 and reviewed by the Hematology panel. Devices under QHS reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology
Classification
| Field | Value |
|---|---|
| Device name | Anti-Human Globulin |
| Device class | Unclassified |
| Regulation | 21 CFR 660.50 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | Contact FDA |
Recalls for QHS devices
openFDA lists no recalls for product code QHS.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J0850 — Injection, cytomegalovirus immune globulin intravenous (human), per vial
- J1670 — Injection, tetanus immune globulin, human, up to 250 units
- J2788 — Injection, rho d immune globulin, human, minidose, 50 micrograms (250 i.u.)
- J2791 — Injection, rho(d) immune globulin (human), (rhophylac), intramuscular or intravenous, 100 iu
- J2792 — Injection, rho d immune globulin, intravenous, human, solvent detergent, 100 iu
Frequently asked questions
What is FDA product code QHS?
QHS is the FDA product code for anti-human globulin. It is a Unclassified device, regulated under 21 CFR 660.50 and reviewed by the Hematology panel.
What device class is QHS?
Unclassified, regulation 21 CFR 660.50. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QHS
- Run a recall and safety report across every QHS manufacturer
- Watch product code QHS 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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