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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.
 
DeviceIMMULITE AFP AND IMMULITE 2000 AFP
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
511 BENEDICT AVE.
TARRYTOWN, NY 10591
PMA NumberP010007
Supplement NumberS001
Date Received01/21/2003
Decision Date02/24/2003
Product Code LOK 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR USE OF THE IMMULITE AFP ON THE IMMULITE 1000 AUTOMATED ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE/IMMULITE 1000 AFP AND IS INDICATED: FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE AND IMMULTE 1000 ANALYZERS - 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) MEASUREMENTS 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.
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