FDA product code QIV: Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
QIV is the FDA product code for culture-based short-term incubation antimicrobial resistance assay. It is a Class II device, regulated under 21 CFR 866.1655 and reviewed by the Microbiology panel. Devices under QIV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection.
Classification
| Field | Value |
|---|---|
| Device name | Culture-Based Short-Term Incubation Antimicrobial Resistance Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.1655 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for QIV devices
openFDA lists no recalls for product code QIV.
Frequently asked questions
What is FDA product code QIV?
QIV is the FDA product code for culture-based short-term incubation antimicrobial resistance assay. It is a Class II device, regulated under 21 CFR 866.1655 and reviewed by the Microbiology panel.
What device class is QIV?
Class II, regulation 21 CFR 866.1655. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QIV
- Run a recall and safety report across every QIV manufacturer
- Watch product code QIV 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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