FDA product code GJJ: Stains, Heinz Body
GJJ is the FDA product code for stains, heinz body. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Hematology panel. Devices under GJJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Stains, Heinz Body |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for GJJ devices
openFDA lists no recalls for product code GJJ.
Frequently asked questions
What is FDA product code GJJ?
GJJ is the FDA product code for stains, heinz body. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Hematology panel.
What device class is GJJ?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GJJ
- Run a recall and safety report across every GJJ manufacturer
- Watch product code GJJ 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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