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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceARCHITECT AFP,LN 3P36
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantAbbott Laboratories
09V6 AP5-2N
100 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064
PMA NumberP120008
Supplement NumberS003
Date Received05/13/2013
Decision Date06/12/2013
Product Code LOK 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE FOR THE ADDITION OF A QUALITY CONTROL TEST FOR PROTEIN PURITY OF INCOMING RAW MATERIAL (ALBUMIN BOVINE 30% SOLUTION WITH 0.1% SODIUM AZIDE (BOVINE ALBUMIN SOLUTION) USED IN THE MANUFACTURING OF CONTROLS AND CALIBRATORS FOR THE ARCHITECT AFP ASSAY. DUE TO THE RAW MATERIAL DISTRIBUTOR NOT HAVING A VALIDATED QUALITY CONTROL TEST FOR PROTEIN PURITY, THE ADDITIONAL QUALITY CONTROL TEST WILL BE IMPLEMENTED TO ENSURE THE PROTEIN PURITY OF THE RAW MATERIAL MEETS THE MANUFACTURERS SPECIFICATIONS.
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