THERASCREEN KRAS RGQ PCR KIT
FDA premarket approval P110030 · decided 2012-07-06
Approval details
- PMA number
- P110030
- Trade name
- THERASCREEN KRAS RGQ PCR KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN Manchester, Ltd.
- Date received
- 2011-07-28
- Decision date
- 2012-07-06
- Days to decision
- 344 days
- Decision code
- APWD
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Manchester
- 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 KRA
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