QUL
- Product code
- QUL
- Device name
- Immunohistochemistry Assay, Antibody, Folr1
- Device class
- Class 3
- 21 CFR
- 21 CFR 864.1860
- Medical specialty
- Hematology
- Marketing pathway
- PMA
FDA classification 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.
Official FDA classification page: QUL
Classification and pathway per current FDA publications. Data from openFDA (CC0).