QUL — Immunohistochemistry Assay, Antibody, Folr1 Class III
FDA product code QUL covers "Immunohistochemistry Assay, Antibody, Folr1", a Class III medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- QUL
- Device Class
- Class III
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
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.