FDA product code JGD: Nephelometric Method, Globulin
JGD is the FDA product code for nephelometric method, globulin. It is a Class I device, regulated under 21 CFR 862.1330 and reviewed by the Clinical Chemistry panel. Devices under JGD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Nephelometric Method, Globulin |
| Device class | Class I |
| Regulation | 21 CFR 862.1330 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JGD devices
openFDA lists no recalls for product code JGD.
Frequently asked questions
What is FDA product code JGD?
JGD is the FDA product code for nephelometric method, globulin. It is a Class I device, regulated under 21 CFR 862.1330 and reviewed by the Clinical Chemistry panel.
What device class is JGD?
Class I, regulation 21 CFR 862.1330. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JGD
- Run a recall and safety report across every JGD manufacturer
- Watch product code JGD 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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