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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namechemiluminescent immunoassay for in vitro diagnostic quantitation of afp in maternal and amniotic fluid
PMA NumberP980041
Supplement NumberS024
Date Received04/12/2013
Decision Date08/20/2013
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product 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.