PMA P030044S001
- Device
- DAKOCYTOMATION EGFR PHARMDX KIT
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P030044
- Supplement
- S001
- Product code
- NQF
- Decision date
- 2006-02-01
- Classification
- Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
- Generic name
- Immunohistochemistry assay, antibody, epidermal growth factor receptor
- Approval order statement
- APPROVAL FOR ADDITIONAL LABELING CHANGES INCLUDE A CLARIFICATION IN THE DEFINITION OF POSITIVE STAINING FOR INDIVIDUAL TUMOR CELLS, INCLUSION OF LIMITATION ABOUT CETUXIMAB RESPONSE RATE FOR NEGATIVE/ POSITIVE PATIENTS AND PERFORMANCE INDICES FOR PATIENTS WHO HAD <1% POSITIVE TUMOR CELLS FOR EGFR.
Current openFDA PMA Record#
- Device
- DAKOCYTOMATION EGFR PHARMDX KIT
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P030044
- Supplement
- S001
- Product code
- NQF
- Generic name
- Immunohistochemistry assay, antibody, epidermal growth factor receptor
- Decision date
- 2006-02-01
- Decision code
- APPR
- Date received
- 2005-11-17
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDITIONAL LABELING CHANGES INCLUDE A CLARIFICATION IN THE DEFINITION OF POSITIVE STAINING FOR INDIVIDUAL TUMOR CELLS, INCLUSION OF LIMITATION ABOUT CETUXIMAB RESPONSE RATE FOR NEGATIVE/ POSITIVE PATIENTS AND PERFORMANCE INDICES FOR PATIENTS WHO HAD