PMA P120022S009
- Device
- QIAGEN THERASCREEN EGFR RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S009
- Product code
- OWD
- Decision date
- 2015-04-24
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- APPROVAL FOR REPLACEMENT OF THE RAW MATERIALS USED IN MANUFACTURING OF PRIMARY PACKAGING (BOTTLES AND CAPS) FOR BUFFERS IN THE QIAAMP DSP DNA FFPE TISSUE KIT.
Current openFDA PMA Record#
- Device
- QIAGEN THERASCREEN EGFR RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S009
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2015-04-24
- Decision code
- APPR
- Date received
- 2015-01-26
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR REPLACEMENT OF THE RAW MATERIALS USED IN MANUFACTURING OF PRIMARY PACKAGING (BOTTLES AND CAPS) FOR BUFFERS IN THE QIAAMP DSP DNA FFPE TISSUE KIT.