FDA product code QTU: Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests
QTU is the FDA product code for reagents, non-variola orthopoxvirus or monkeypox virus singleplex antigen tests. It is a Not classified device, reviewed by the Microbiology panel. Devices under QTU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY
Classification
| Field | Value |
|---|---|
| Device name | Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for QTU devices
openFDA lists no recalls for product code QTU.
Frequently asked questions
What is FDA product code QTU?
QTU is the FDA product code for reagents, non-variola orthopoxvirus or monkeypox virus singleplex antigen tests. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QTU?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QTU
- Run a recall and safety report across every QTU manufacturer
- Watch product code QTU 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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