|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||THXID BRAF KIT|
|Classification Name||somatic gene mutation detection system|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for addition of a quality control test for the thxid¿-braf master mix.