Immunohistochemistry Assay, Antibody, Folr1

QUL · Class III — High Risk (PMA approval required, life-sustaining) · Hematology · 21 CFR 864.1860

Classification

FDA Product Code: QUL
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: 21 CFR 864.1860
Review panel: PA
Medical specialty: Hematology
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown