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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namekit, test, alpha-fetoprotein for neural tube defects
PMA NumberP970037
Date Received08/26/1997
Decision Date03/31/1998
Product Code
LOK[ Registered Establishments with LOK ]
Docket Number 98M-0306
Notice Date 05/27/1998
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The device is intended for the quantitative determination of human alpha-fetoprotein (afp) in maternal serum and amniotic fluid obtained between the 15th and 21st weeks of gestation. The assay is to be peformed on the 1235 autodelfia(tm) automatic immunoassay system, and is intended for use only in conjunction with other diagnostic tools such as ultrasound and amniography as an aid in the detection of open neural tube defects (ontds).
Supplements: S001 S002 S003 S004 S005 S006 S007 S008