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Device | THERASCREEN KRAS RGQ PCR KIT |
Generic Name | somatic gene mutation detection system |
Applicant |
QIAGEN MANCHESTER LTD |
skeleton house, lloyd street north |
manchester |
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PMA Number | P110030 |
Date Received | 07/28/2011 |
Decision Date | 07/06/2012 |
Withdrawal Date
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11/07/2014 |
Product Code |
OWD
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Docket Number | 12M-0735 |
Notice Date | 07/16/2012 |
Advisory Committee |
Pathology |
Clinical Trials |
NCT00079066
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Expedited Review Granted? | No |
Combination Product |
Yes
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Approval Order Statement
APPROVAL FOR THE THERASCREEN KRAS RGQ PCR KIT. THIS DEVICE IS INDICATED FOR: THE THERASCREEN KRAS RGQ PCR KIT IS A REAL-TIME QUALITATIVE PCR ASSAY USED ON THE ROTORGENE Q MDX INSTRUMENT FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN THE HUMAN KRAS ONCOGENE, USING DNA EXTRACTED FROM FORMALIN FIXED PARAFFIN-EMBEDDED (FFPE), COLORECTAL CANCER (CRC) TISSUE. THE THERASCREEN KRAS RGQ PCR KIT IS INTENDED TO AID IN THE IDENTIFICATION OF CRC PATIENTS FOR TREATMENT WITH ERBITUX (CETUXIMAB) BASED ON A KRAS NO MUTATION DETECTED TEST RESULT. |
Approval Order |
Approval Order
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Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
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Supplements: |
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