PMA P120022S007
- Device
- THERASCREEN EGFR RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S007
- Product code
- OWD
- Decision date
- 2015-02-19
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- CHANGE OF FILLING PROCESS FOR PROTEINASE K IN THE QIAAMP DSP DNA FFPE TISSUE KIT FROM A MANUAL TO AN AUTOMATED PROCESS AT THE HILDEN, GERMANY FACILITY.
Current openFDA PMA Record#
- Device
- THERASCREEN EGFR RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S007
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2015-02-19
- Decision code
- OK30
- Date received
- 2015-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF FILLING PROCESS FOR PROTEINASE K IN THE QIAAMP DSP DNA FFPE TISSUE KIT FROM A MANUAL TO AN AUTOMATED PROCESS AT THE HILDEN, GERMANY FACILITY.