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Device | ACCESS AFP IMMUNOASSAY SYSTEM |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P980041 |
Date Received | 10/16/1998 |
Decision Date | 02/08/1999 |
Product Code |
LOK |
Docket Number | 99M-0793 |
Notice Date | 04/08/1999 |
Advisory Committee |
Immunology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Access(R) AFP Reagents on the Access(R) Immunoassay Analyzer. The Access(R) AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access(R) Immunoassay System for the quantitative determination fo alpha-fetoprotein (AFP) in: 1)Human seru, as an aid in management of patients with non-seminomatous testicular cancer. 2) Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S039 S040 S041 S043 S044 S045 S046 S047 S048 S049 S050 |