FDA product code QTP: Reagents, Monkeypox Virus Nucleic Acid.
QTP is the FDA product code for reagents, monkeypox virus nucleic acid.. It is a Not classified device, reviewed by the Microbiology panel. Devices under QTP 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 monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens
Classification
| Field | Value |
|---|---|
| Device name | Reagents, Monkeypox Virus Nucleic Acid. |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QTP devices
openFDA lists no recalls for product code QTP.
Frequently asked questions
What is FDA product code QTP?
QTP is the FDA product code for reagents, monkeypox virus nucleic acid.. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QTP?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QTP
- Run a recall and safety report across every QTP manufacturer
- Watch product code QTP 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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