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