Changes to in-process qc testing
Device | therascreen FGFR RGQ PCR Kit |
Generic Name | Somatic Gene Mutation Detection System |
Applicant | QIAGEN GmbH |
Date Received | 2020-03-04 |
Decision Date | 2020-04-03 |
PMA | P180043 |
Supplement | S002 |
Product Code | OWD |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | QIAGEN GmbH qiagen Strasse 1 hilden |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P180043 | | Original Filing |
S003 |
2021-09-20 |
Real-time Process |
S002 |
2020-03-04 |
30-day Notice |
S001 | | |
NIH GUDID Devices