QZJ — Immunohistochemistry Assay, Antibody, Claudin 18 Class III
FDA product code QZJ covers "Immunohistochemistry Assay, Antibody, Claudin 18", a Class III medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- QZJ
- Device Class
- Class III
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
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.