PMA P120022S019
- Device
- therascreen EGFR RGQ PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S019
- Product code
- OWD
- Decision date
- 2018-04-06
- Classification
- Somatic Gene Mutation Detection System
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Change the supplier and the polymer used for a kit consumable.
Current openFDA PMA Record#
- Device
- therascreen EGFR RGQ PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P120022
- Supplement
- S019
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2018-04-06
- Decision code
- OK30
- Date received
- 2018-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the supplier and the polymer used for a kit consumable.