FDA product code QIO: Anaplasma Spp. And Ehrlichia Spp. Serological Reagents
QIO is the FDA product code for anaplasma spp. and ehrlichia spp. serological reagents. It is a Not classified device, reviewed by the Microbiology panel. Devices under QIO reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Tests or reagents used to detect IgG and/or IgM antibodies to Anaplasma spp. and/or Ehrlichia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Anaplasma spp. and/or Ehrlichia spp. in patients suspected of exposure.
Classification
| Field | Value |
|---|---|
| Device name | Anaplasma Spp. And Ehrlichia Spp. Serological Reagents |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for QIO devices
openFDA lists no recalls for product code QIO.
Frequently asked questions
What is FDA product code QIO?
QIO is the FDA product code for anaplasma spp. and ehrlichia spp. serological reagents. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QIO?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QIO
- Run a recall and safety report across every QIO manufacturer
- Watch product code QIO 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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