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Device | THERASCREEN KRAS RGQ PCR KIT |
Generic Name | Somatic gene mutation detection system |
Applicant | QIAGEN GmbH QIAGEN Strasse 1 Hilden 40724 |
PMA Number | P110027 |
Supplement Number | S003 |
Date Received | 12/22/2014 |
Decision Date | 01/16/2015 |
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 TO THE SUPPLIERS PURITY TESTING METHOD FOR THE INTERNAL CONTROL TEMPLATE IN YOUR THERASCREEN KRAS RGQ PCR KIT. THE NEW PURITY TESTING WILL USE REVERSED PHASE-ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY (RP-UPLC) WITH A CHANGE IN ACCEPTANCE CRITERION FROM >=90% TO >=80%. |