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U.S. Department of Health and Human Services

Product Classification

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Device immunohistochemistry assay, antibody, programmed death-ligand 1
Regulation Description Immunohistochemistry reagents and kits.
Definition The programmed death-ligand 1 (pd-l1) antibody is a qualitative immunohistochemical antibody intended to identify pd-l1 protein expression in human clinical tissue specimens.The pd-l1 antibody is indicated as an aid in identifying patients eligible for treatment with specific fda approved therapeutic drugs or to assess pd-l1 expression level in patients who may respond particularly well to 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 Human clinical tissue specimens
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodePLS
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Regulation Number 864.1860
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible