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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDAKO EGFR PHARMDX KIT
Classification Nameimmunohistochemistry assay, antibody, epidermal growth factor receptor
Generic Namedakocytomation mouse anti-human egfr immunohistochemistry kit
Regulation Number864.1860
ApplicantDAKO NORTH AMERICA, INC.
PMA NumberP030044
Supplement NumberS002
Date Received04/25/2006
Decision Date09/27/2006
Product Code
NQF[ Registered Establishments with NQF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding a new therapy vectibix (panitumumab) to intended use. The device, as modified, will be marketed under the trade name dako egfr pharmdx kit and 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 neoplatic tissues routinely-fixed for histological evaluatin. 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), or vectibix (panitumumab).
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