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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 AXSYM AFP
Classification Namekit, test,alpha-fetoprotein for testicular cancer
Generic Nameafp-eia diagnostic kit
Regulation Number866.6010
ApplicantABBOTT LABORATORIES
PMA NumberP820060
Supplement NumberS011
Date Received04/21/1997
Decision Date05/16/1997
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the addition of a system performed automated dilution protocol for a 1:101 sample dilution of amniotic fluid and is indicated for the quantitative determination of alpha-fetoprotein (afp) in: 1)human serum or plasma to aid in the management of patients with nonseminomatous testicular cancer. (2) human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation ot aid int he detection of fetal open neural tube detects (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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