|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||RAPID FFN CONTROL KIT|
|Classification Name||enzyme immunoassay, fetal fibronectin|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to add an intermediate solution in the manufacturing process of positive reference calibrator, to modify the personnel in charge of in-process manufacturing testing and to increase the number of replicates in bulk solution concentration verification procedure for both positive reference calibrator and positive control. The positive reference calibrator and the positive control are components of the rapid ffn control kit for use with the tliiq analyzer and ffn elisa test.