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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
PMA NumberP120008
Supplement NumberS003
Date Received05/13/2013
Decision Date06/12/2013
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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.