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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.
 
Trade NameACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namechemiluminescent immunoassay for in vitro diagnostic quantitation of afp in maternal and amniotic fluid
ApplicantBECKMAN COULTER, INC.
PMA NumberP980041
Supplement NumberS017
Date Received03/15/2012
Decision Date04/13/2012
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 new information to be added to the instructions for use, the operators guide and the reference manual, including the following: 1) add instructions to the weekly maintenance sections of these documents for the inspection of the liquid waste bottles; 2) clarify pack mixing instructions; 3) add troubleshooting steps; 4) change cautions into warnings; and 5) change notes into warnings.
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