FDA product code QUL

Immunohistochemistry Assay, Antibody, Folr1

Hematology·Class 3·21 CFR 864.1860
US regulatory classifications
US Product Code (FDA)
QUL
View Product Code Classification →
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 864.1860
View CFR Regulation →
Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords
About this record

Immunohistochemistry Assay, Antibody, Folr1 is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.