PMA P110027S015
- Device
- therascreen KRAS RGQ PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P110027
- Supplement
- S015
- Product code
- OWD
- Decision date
- 2022-07-11
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Addition of a calibration step for manufacturing Internal Control
Current openFDA PMA Record#
- Device
- therascreen KRAS RGQ PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P110027
- Supplement
- S015
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2022-07-11
- Decision code
- OK30
- Date received
- 2022-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a calibration step for manufacturing Internal Control