FDA product code JQI: Rotating Disc, Plasma Viscometry
JQI is the FDA product code for rotating disc, plasma viscometry. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. Devices under JQI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Rotating Disc, Plasma Viscometry |
| Device class | Class I |
| Regulation | 21 CFR 862.1475 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JQI devices
openFDA lists no recalls for product code JQI.
Frequently asked questions
What is FDA product code JQI?
JQI is the FDA product code for rotating disc, plasma viscometry. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.
What device class is JQI?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JQI
- Run a recall and safety report across every JQI manufacturer
- Watch product code JQI 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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