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