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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDAKOCYTOMATION C-KIT PHARMDX
Classification Nameimmunohistochemistry antibody assay, c-kit
Generic Namedakocytomation rabbit anti-human c-kit immunohistochemistry kit
Regulation Number864.1860
ApplicantDAKO NORTH AMERICA, INC.
PMA NumberP040011
Date Received03/25/2004
Decision Date06/27/2005
Product Code
NKF[ Registered Establishments with NKF ]
Docket Number 05M-0388
Notice Date 09/23/2005
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the dakocytomation c-kit pharmdx. Dakocytomation c-kit pharmdx on the dako autostainer: the c-kit pharmdx assay is a qualitative immunohistochemical (ihc) kit system used on the dako autostainer, for the identification of c-kit protein/cd117 antigen (c-kit protein) expression in normal and neoplastic formalin-fixed paraffin-embedded tissues for histological evaluation. The c-kit pharmdx rabbit polyclonal antibodies specifically detect the c-kit protein in cd117 antigen-expressing cells. The c-kit pharmdx is indicated as an aid in the differential diagnosis of gastrointestinal stromal tumors (gist). After diagnosis of gist, results from c-kit pharmdx may be used as an aid in identifying those patients eligible for treatment with gleevec/glivec (imatinib mesylate). Results from hematoxylin and eosin (h&e) stains and a panel of antibodies can aid in the differential diagnosis of gist. Interpretation must be made by a qualified pathologist, within the context of a patient's clinical history, proper controls, and other diagnostic test. Dako cytomation c-kit pharmdx for manual use: the c-kit pharmdx assay is a qualitative immunohistochemical (ihc) kit system used for the identification of c-kit protein/cd117 antigen (c-kit protein) expression in normal and neoplastic formalin-fixed paraffin-embedded tissues for histological evaluation. The c-kit pharmdx rabbit polyclonal. Antibodies specifically detect the c-kit protein in cd117 antigen-expressing cells. The c-kit pharmdx is indicated as an aid in the differential diagnosis of gastrointestinal stromal tumors (gist). After diagnosis of gist, results from c-kit pharmdx may be used as an aid in identifying those patients eligible for treatment with gleevec/glivec (imatinib mesylate). Results from hematoxylin and eosin (h&e) stains and a panel of antibodies can aid in the differential diagnosis of gist. Interpretation must be made by a qualified pathologist, within the context of a patient's.
Approval Order Approval Order
Supplements: S001 S002 
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