FDA product code QHM: Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
QHM is the FDA product code for serology tests used for infectious disease screening of blood and plasma donations. It is a Unclassified device, regulated under 21 CFR 610.40 and reviewed by the Microbiology panel. Devices under QHM reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens
Classification
| Field | Value |
|---|---|
| Device name | Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations |
| Device class | Unclassified |
| Regulation | 21 CFR 610.40 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | Contact FDA |
Recalls for QHM devices
openFDA lists no recalls for product code QHM.
Frequently asked questions
What is FDA product code QHM?
QHM is the FDA product code for serology tests used for infectious disease screening of blood and plasma donations. It is a Unclassified device, regulated under 21 CFR 610.40 and reviewed by the Microbiology panel.
What device class is QHM?
Unclassified, regulation 21 CFR 610.40. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QHM
- Run a recall and safety report across every QHM manufacturer
- Watch product code QHM 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.