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Device | IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 BENEDICT AVE. TARRYTOWN, NY 10591 |
PMA Number | P010007 |
Date Received | 02/13/2001 |
Decision Date | 11/09/2001 |
Product Code |
LOK |
Docket Number | 01M-0537 |
Notice Date | 12/05/2001 |
Advisory Committee |
Immunology |
Expedited Review Granted? | No |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 |