|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||ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS|
|Applicant||BECKMAN COULTER, INC.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for updating the labeling of unicel dx1 instructions for use, operator's guide, reference manual and onboard system help. Requested changes to the labeling include changing current caution statements to warning statements (to enhance the safety of the operator, and removing redundant caution statements), adding new caution statements (notes for procedure clarification), adding new warning statements, changing warning to caution and relocating existing warning/caution statements in order to enhance the safety in the use of the reagents on the unicel dxl 800/600 immunoassay systems and unicel dxc 880i/860i/680i/ 660i synchron access integrated clinical systems.