PMA P120022S012
- Device
- THERASCREEN EGFR RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S012
- Product code
- OWD
- Decision date
- 2015-11-09
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN GMBH IN HILDEN, GERMANY.
Current openFDA PMA Record#
- Device
- THERASCREEN EGFR RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S012
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2015-11-09
- Decision code
- APPR
- Date received
- 2015-09-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN GMBH IN HILDEN, GERMANY.