PMA P110027S006

Device
QIAGEN THERASCREEN KRAS RGQ PCR KIT
Applicant
QIAGEN GmbH
PMA number
P110027
Supplement
S006
Product code
OWD
Decision date
2015-04-23
Classification
Somatic Gene Mutation Detection System
Generic name
Somatic gene mutation detection system
Approval order statement
APPROVAL FOR REPLACEMENT OF LYSIS TUBE IN THE QIAAMP DSP DNA FFPE TISSUE KIT.

Current openFDA PMA Record#

Device
QIAGEN THERASCREEN KRAS RGQ PCR KIT
Applicant
QIAGEN GmbH
PMA number
P110027
Supplement
S006
Product code
OWD
Generic name
Somatic gene mutation detection system
Decision date
2015-04-23
Decision code
APPR
Date received
2015-01-26
Supplement type
Real-Time Process
Approval order statement
APPROVAL FOR REPLACEMENT OF LYSIS TUBE IN THE QIAAMP DSP DNA FFPE TISSUE KIT.