FDA product code QUL: Immunohistochemistry Assay, Antibody, Folr1
QUL is the FDA product code for immunohistochemistry assay, antibody, folr1. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. Devices under QUL reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The FOLR1 antibody is a qualitative immunohistochemical antibody intended to identify FOLR1 protein expression in human clinical tissue specimens. The FOLR-1 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, Folr1 |
| Device class | Class III |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | PMA |
Recalls for QUL devices
openFDA lists no recalls for product code QUL.
Frequently asked questions
What is FDA product code QUL?
QUL is the FDA product code for immunohistochemistry assay, antibody, folr1. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is QUL?
Class III, regulation 21 CFR 864.1860. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QUL
- Run a recall and safety report across every QUL manufacturer
- Watch product code QUL 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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