PMA P190001S002
- Device
- therascreen® PIK3CA RGQ PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P190001
- Supplement
- S002
- Product code
- OWD
- Decision date
- 2025-10-22
- Classification
- Medical Genetics
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Approval for a software update for the therascreen® PIK3CA RGQ PCR Kit
Current openFDA PMA Record#
- Device
- therascreen® PIK3CA RGQ PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P190001
- Supplement
- S002
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2025-10-22
- Decision code
- APPR
- Date received
- 2024-05-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software update for the therascreen® PIK3CA RGQ PCR Kit