|
Device | Therascreen EGFR, RGQ, PCR Kit |
Generic Name | Somatic gene mutation detection system |
Applicant | QIAGEN GmbH QIAGEN Strasse 1 Hilden 40724 |
PMA Number | P120022 |
Supplement Number | S015 |
Date Received | 06/29/2017 |
Decision Date | 07/24/2017 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Improvement to the therascreen EFGR Kit stock Internal Control (IC) Mix manufacturing process. |