FDA product code QIP: Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents
QIP is the FDA product code for rickettsia spp. (spotted fever group or typhus group) serological reagents. It is a Not classified device, reviewed by the Microbiology panel. Devices under QIP 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 Ricketsia spp. (Spotted Fever Group or Typhus Group) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Ricketsia spp. in patients suspected of exposure.
Classification
| Field | Value |
|---|---|
| Device name | Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for QIP devices
openFDA lists no recalls for product code QIP.
Frequently asked questions
What is FDA product code QIP?
QIP is the FDA product code for rickettsia spp. (spotted fever group or typhus group) serological reagents. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QIP?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QIP
- Run a recall and safety report across every QIP manufacturer
- Watch product code QIP 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.