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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER
Classification Namekit, test,alpha-fetoprotein for testicular cancer
Generic Nameafp-eia diagnostic kit
Regulation Number866.6010
ApplicantABBOTT LABORATORIES
PMA NumberP820060
Supplement NumberS016
Date Received11/26/2002
Decision Date02/02/2004
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the abbott architect afp assay on the architect i2000sr analyzer. The device, as modified, will be marketed under the trade name abbott architect afp assay for the architect i2000 analyzer and is indicated for the following: 1) human serum or plasma to aid in the management of patients with nonseminomatosus testicular cancer. 2) human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of open neural tube defects (ntd). Test results when used in conjunction with ultrasonography or amniography are a safe and effective aid in the detection of fetal open ntd.
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