Dakocytomation Egfr Pharmdx
FDA premarket approval P030044 · Immunohistochemistry assay, antibody, epidermal growth factor receptor
PMA numberP030044
Approval
- Applicant
- Agilent Technologies, Inc.
- Received
- September 29, 2003
- Decision date
- February 12, 2004 (APWD)
- Supplements
- 7, latest March 13, 2019
- Product code
- NQF – Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
Approval order statement
APPROVAL FOR THE DAKOCYTOMATION EGFR PHARMDX. THE DEVICE IS INDICATED FOR: THE EGFR PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM TO IDENTIFY EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXPRESSION IN NORMAL AND NEOPLASTIC TISSUES ROUTINELY-FIXED FOR HISTOLOGICAL EVALUATION. EGFR PHARMDX SPECIFICALLY DETECTS THE EGFR (HER1) PROTEIN IN EGFR-EXPRESSING CELLS. EGFR PHARMDX IS INDICATED AS AN AID IN IDENTIFYING COLORECTAL CANCER PATIENTS ELIGIBLE FOR TREATMENT WITH ERBITUX (CETUXIMAB).