PMA P120022S017
- Device
- therascreen EGFR RGQ PCR kit
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S017
- Product code
- OWD
- Decision date
- 2018-02-22
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Transfer of the sub-process of standards manufacturing to another manufacturing site.
Current openFDA PMA Record#
- Device
- therascreen EGFR RGQ PCR kit
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S017
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2018-02-22
- Decision code
- OK30
- Date received
- 2018-01-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of the sub-process of standards manufacturing to another manufacturing site.