PMA P180043S010

Device: QIAGEN therascreen® FGFR RGQ RT-PCR Kit
Applicant: QIAGEN GmbH
PMA number: P180043
Supplement: S010
Product code: OWD
Decision date: 2026-05-06
Classification: Medical Genetics
Generic name: Somatic gene mutation detection system
Approval order statement: Approval for a minor material change which would replace the BSA (Bovine Serum Album) in the PCR Master Mix tubes with a recombinant Human Serum Albumin (rHSA).

Current openFDA PMA Record#

Device: QIAGEN therascreen® FGFR RGQ RT-PCR Kit
Applicant: QIAGEN GmbH
PMA number: P180043
Supplement: S010
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2026-05-06
Decision code: APPR
Date received: 2026-02-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a minor material change which would replace the BSA (Bovine Serum Album) in the PCR Master Mix tubes with a recombinant Human Serum Albumin (rHSA).