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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 NameQUANTITOPE 125I AFP KIT AND CONTROL SERUM
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Name125i afp kit
ApplicantBIO-RAD LABORATORIES, INC.
PMA NumberP800025
Supplement NumberS005
Date Received12/21/1995
Decision Date10/02/1996
Product Code
LOK[ Registered Establishments with LOK ]
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 
Replacement of the current radiolabeled afp with a new afp antigen.
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