PMA P120022S014
- Device
- THERASCREEN EGFR RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S014
- Product code
- OWD
- Decision date
- 2017-05-19
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Approval for changes to the Instructions for Use.
Current openFDA PMA Record#
- Device
- THERASCREEN EGFR RGQ PCR KIT
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S014
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2017-05-19
- Decision code
- APPR
- Date received
- 2016-12-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the Instructions for Use.