|
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 | S007 |
Date Received | 01/21/2015 |
Decision Date | 02/19/2015 |
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 CHANGE OF FILLING PROCESS FOR PROTEINASE K IN THE QIAAMP DSP DNA FFPE TISSUE KIT FROM A MANUAL TO AN AUTOMATED PROCESS AT THE HILDEN, GERMANY FACILITY. |