FDA product code QZG: Menstrual Blood Collection Device
QZG is the FDA product code for menstrual blood collection device. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel. Devices under QZG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended to collect and transport menstrual blood specimens to the laboratory for in vitro diagnostic testing
Classification
| Field | Value |
|---|---|
| Device name | Menstrual Blood Collection Device |
| Device class | Class II |
| Regulation | 21 CFR 862.1675 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
Recalls for QZG devices
openFDA lists no recalls for product code QZG.
Frequently asked questions
What is FDA product code QZG?
QZG is the FDA product code for menstrual blood collection device. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel.
What device class is QZG?
Class II, regulation 21 CFR 862.1675. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QZG
- Run a recall and safety report across every QZG manufacturer
- Watch product code QZG 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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