FDA product code QIQ: Orientia Spp. (Scrub Typhus) Serological Reagents
QIQ is the FDA product code for orientia spp. (scrub typhus) serological reagents. It is a Not classified device, reviewed by the Microbiology panel. Devices under QIQ 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 Orientia spp. (Scrub Typhus) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Orientia spp. in patients suspected of exposure.
Classification
| Field | Value |
|---|---|
| Device name | Orientia Spp. (Scrub Typhus) Serological Reagents |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for QIQ devices
openFDA lists no recalls for product code QIQ.
Frequently asked questions
What is FDA product code QIQ?
QIQ is the FDA product code for orientia spp. (scrub typhus) serological reagents. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QIQ?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QIQ
- Run a recall and safety report across every QIQ manufacturer
- Watch product code QIQ 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times