PMA P120022S015
- Device
- Therascreen EGFR, RGQ, PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S015
- Product code
- OWD
- Decision date
- 2017-07-24
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Improvement to the therascreen EFGR Kit stock Internal Control (IC) Mix manufacturing process.
Current openFDA PMA Record#
- Device
- Therascreen EGFR, RGQ, PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S015
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2017-07-24
- Decision code
- OK30
- Date received
- 2017-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Improvement to the therascreen EFGR Kit stock Internal Control (IC) Mix manufacturing process.