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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 AFP 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 NumberS014
Date Received01/10/2011
Decision Date02/07/2011
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 to add the following new warning label to all access dxi systems. ¿warning¿ erroneous results can occur if reagent packs are not loaded properly. 1) never transfer a partial reagent pack that was used on a different system. 2) always load a reagent pack before scanning the bar code (access/ access 2 only). For specific instructions, consult the system documentation.
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