FDA product code QKO: Reagent, Coronavirus Serological
QKO is the FDA product code for reagent, coronavirus serological. It is a Not classified device, reviewed by the Microbiology panel. Devices under QKO reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 31 recalls for QKO devices, 8 initiated in the last five years.
Definition
The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Coronavirus Serological |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QKO devices
31 product recalls in 23 recall events; 8 initiated in the last five years and 7 still open. Most recent: 2023-05-22.
| Year | Recalls |
|---|---|
| 2020 | 10 |
| 2021 | 14 |
| 2022 | 5 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code QKO?
QKO is the FDA product code for reagent, coronavirus serological. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QKO?
Not classified. Typical premarket route: PMA.
Have QKO devices been recalled?
Yes: 31 product recalls across 23 recall events; the most recent began 2023-05-22.
Next steps
- Run an FDA pathway report with predicate devices for product code QKO
- Run a recall and safety report across every QKO manufacturer
- Watch product code QKO 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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