QZJ
- Product code
- QZJ
- Device name
- Immunohistochemistry Assay, Antibody, Claudin 18
- Device class
- Class 3
- 21 CFR
- 21 CFR 864.1860
- Medical specialty
- Hematology
- Marketing pathway
- PMA
FDA classification 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.
Official FDA classification page: QZJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).