PMA P110027S008
- Device
- THERASCREEN KRAS RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P110027
- Supplement
- S008
- Product code
- OWD
- Decision date
- 2015-08-06
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- APPROVAL FOR THE CHANGE IN MANUFACTURING OF A CRITICAL REAGENT (TAQ POLYMERASE) AND THE CONVERSION OF A MANUAL REAGENT FILL PROCESS TO ONE THAT IS AUTOMATED.
Current openFDA PMA Record#
- Device
- THERASCREEN KRAS RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P110027
- Supplement
- S008
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2015-08-06
- Decision code
- APPR
- Date received
- 2015-02-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE CHANGE IN MANUFACTURING OF A CRITICAL REAGENT (TAQ POLYMERASE) AND THE CONVERSION OF A MANUAL REAGENT FILL PROCESS TO ONE THAT IS AUTOMATED.