PMA P180043S007
- Device
- QIAGEN therascreen® FGFR RGQ RT-PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P180043
- Supplement
- S007
- Product code
- OWD
- Decision date
- 2025-10-03
- Classification
- Medical Genetics
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Approval for an update to the software used to interpret the amplification curve for a positive sample or positive control during the PCR reaction.
Current openFDA PMA Record#
- Device
- QIAGEN therascreen® FGFR RGQ RT-PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P180043
- Supplement
- S007
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2025-10-03
- Decision code
- APPR
- Date received
- 2024-03-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an update to the software used to interpret the amplification curve for a positive sample or positive control during the PCR reaction.