|
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 | S010 |
Date Received | 02/18/2015 |
Decision Date | 08/06/2015 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CHANGE IN MANUFACTURING OF A CRITICAL REAGENT (TAQ POLYMERASE)AND THE CONVERSION OF A MANUAL REAGENT FILL PROCESS TO ONE THAT IS AUTOMATED. |