|
Device | QIAGEN 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 | S006 |
Date Received | 01/21/2015 |
Decision Date | 02/13/2015 |
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 NEW ASSEMBLY LINE FOR MANUFACTURING (ASSEMBLING) QIAAMP MINELUTE SPIN COLUMNS USED TO ISOLATE AND PURIFY DNA. |