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...
| Device | C-KIT PHARMDX |
| Classification Name | Immunohistochemistry Antibody Assay, C-kit |
| Generic Name | Immunohistochemistry Antibody Assay, C-kit |
| Applicant | DAKO NORTH AMERICA, INC. |
| Date Received | 2004-03-12 |
| Decision Date | 2005-06-27 |
| Notice Date | 2005-09-23 |
| PMA | P040011 |
| Supplement | S |
| Product Code | NKF |
| Docket Number | 05M-0388 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040011 | | Original Filing |
| S003 |
2017-04-17 |
30-day Notice |
| S002 |
2012-10-16 |
Normal 180 Day Track No User Fee |
| S001 |
2007-03-29 |
30-day Notice |
NIH GUDID Devices