THERASCREEN EGFR RGQ PCR KIT
FDA premarket approval P120022/S013 · decided 2016-09-07
Approval details
- PMA number
- P120022
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERASCREEN EGFR RGQ PCR KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2016-08-10
- Decision date
- 2016-09-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- Change to the mean Ct specification for the positive control (PC) at the final kit release stage and the target Ct value for the manufacturing adjustment process for the L861Q reaction mix.
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