NTR · Class I · 21 CFR 864.1860

FDA Product Code NTR: Immunohistochemical Reagent, Antibody (monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

Monoclonal Or Polyclonal Antibody That Recognizes The Human P63 Protein In The Nucleus Of Prostatic Basal Cells Using Routine Immunohistochemical Techniques, Including Heat-induced Antigen Epitope Retrieval. This Test Is Intended For Laboratory Use To Qualitatively Identify The P63 Antigen In Histological Sections From Formalin-fixed Paraffin-embedded Samples Of Normal And/or Pathological Prostate Tissue Obtained By Needle Biopsy Or Surgical Procedures. The Presence Or Absence Of P63 Staining Aids The Pathologist In The Differential Diagnosis Of Prostate Cancer In Conjunction With Morphological Findings Seen With Hematoxylin And Eosin Staining Complemented By Proper Controls.

1
Total
1
Cleared
29d
Avg days
2005
Since

FDA 510(k) Cleared Immunohistochemical Reagent, Antibody (monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells Devices (Product Code NTR)

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About Product Code NTR - Regulatory Context