FDA product code QHO: Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
QHO is the FDA product code for nucleic-acid 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 QHO reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For the qualitative detection of nucleic acid for infectious disease agents in human specimens.
Classification
| Field | Value |
|---|---|
| Device name | Nucleic-Acid 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 QHO devices
openFDA lists no recalls for product code QHO.
Frequently asked questions
What is FDA product code QHO?
QHO is the FDA product code for nucleic-acid 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 QHO?
Unclassified, regulation 21 CFR 610.40. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QHO
- Run a recall and safety report across every QHO manufacturer
- Watch product code QHO 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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