PMA P190026
- Device
- therascreen BRAF V600E RGQ PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P190026
- Product code
- OWD
- Decision date
- 2023-06-27
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Modify the manufacturing process of the device.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf19/P190026B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- therascreen BRAF V600E RGQ PCR Kit
- Applicant
- QIAGEN GmbH
- PMA number
- P190026
- Supplement
- S001
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2023-06-27
- Decision code
- OK30
- Date received
- 2023-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the manufacturing process of the device.