PMA P180043S008

Device: therascreen FGFR RGQ PCR Kit
Applicant: QIAGEN GmbH
PMA number: P180043
Supplement: S008
Product code: OWD
Decision date: 2024-12-06
Classification: Medical Genetics
Generic name: Somatic gene mutation detection system
Approval order statement: Approval of the Stability Study Protocol for the extension to the shelf-life and the implementation of a new storage condition for the positive control (PC) diluent for the therascreen FGFR RGQ RT-PCR Kit.

Current openFDA PMA Record#

Device: therascreen FGFR RGQ PCR Kit
Applicant: QIAGEN GmbH
PMA number: P180043
Supplement: S008
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2024-12-06
Decision code: APPR
Date received: 2024-06-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of the Stability Study Protocol for the extension to the shelf-life and the implementation of a new storage condition for the positive control (PC) diluent for the therascreen FGFR RGQ RT-PCR Kit.