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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received05/13/1980
Decision Date01/13/1984
Withdrawal Date 04/03/2009
Product Code
LOK[ Registered Establishments with LOK ]
Docket Number 84M-0032
Notice Date 02/17/1985
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 S004 S005 
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