• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device immunohistochemistry assay, antibody, folr1
Regulation Description Immunohistochemistry reagents and kits.
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.
Physical State The device includes a monoclonal primary antibody and accessory reagents, including secondary antibodies, buffers, substrates, and counterstains. The device may be intended for manual or automated staining methods.
Technical Method The test uses a primary monoclonal antibody to detect the presence of expressed antigen protein in fixed tissue specimens. Antibody-antigen complexes are visualized using an enzyme conjugated primary or secondary antibody to catalyze a color-producing reaction.
Target Area Formalin-fixed paraffin-embedded (FFPE) Human clinical tissue specimens
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeQUL
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type PMA
Regulation Number 864.1860
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible