PMA P120022S013

Device: THERASCREEN EGFR RGQ PCR KIT
Applicant: QIAGEN GmbH
PMA number: P120022
Supplement: S013
Product code: OWD
Decision date: 2016-09-07
Classification: Somatic Gene Mutation Detection System
Generic name: Somatic gene mutation detection system
Approval order 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.

Current openFDA PMA Record#

Device: THERASCREEN EGFR RGQ PCR KIT
Applicant: QIAGEN GmbH
PMA number: P120022
Supplement: S013
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2016-09-07
Decision code: OK30
Date received: 2016-08-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.