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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.
 
Trade NameIMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP
Classification Namekit, test, alpha-fetoprotein for neural tube defects
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP010007
Date Received02/13/2001
Decision Date11/09/2001
Product Code
LOK[ Registered Establishments with LOK ]
Docket Number 01M-0537
Notice Date 12/05/2001
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for immulite afp for use with the immulite analyzer and immulite 2000 afp for use with the immulite 2000 analyzer. These devices are indicated for in vitro diagnostic use for the quantitative measurement of alpha-fetoprotein (afp) in either of two contexts: a) serial measurements in human serum to aid in the management of patients with nonseminomatous testicular cancer: or b) measurement in maternal serum and amniotic fluid during gestational weeks 15 through 20 - used in conjunction with ultrasonography or amniography - to aid in detection of fetal open neural tube defects.
Approval Order Approval Order
Supplements: S001 S002 S004 S005 S006 S007 
S008 S009 
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