|
Device | therascreen FGFR RGQ RT-PCR Kit |
Generic Name | Somatic gene mutation detection system |
Applicant | QIAGEN GmbH Qiagen Strasse 1 Hilden |
PMA Number | P180043 |
Supplement Number | S006 |
Date Received | 12/04/2023 |
Decision Date | 12/22/2023 |
Product Code |
OWD |
Advisory Committee |
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Changes to manufacturing process of device components |