FDA product code QZJ: Immunohistochemistry Assay, Antibody, Claudin 18
QZJ is the FDA product code for immunohistochemistry assay, antibody, claudin 18. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. Devices under QZJ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The Claudin 18 antibody is a qualitative immunohistochemical antibody intended to identify CLDN18 protein expression in human clinical tissue specimens. The CLDN18 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemistry Assay, Antibody, Claudin 18 |
| Device class | Class III |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | PMA |
Recalls for QZJ devices
openFDA lists no recalls for product code QZJ.
Frequently asked questions
What is FDA product code QZJ?
QZJ is the FDA product code for immunohistochemistry assay, antibody, claudin 18. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is QZJ?
Class III, regulation 21 CFR 864.1860. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QZJ
- Run a recall and safety report across every QZJ manufacturer
- Watch product code QZJ 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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