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