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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceQUANTITOPE 125I AFP KIT AND CONTROL SERUM
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namekit, test, alpha-fetoprotein for neural tube defects
Applicant
Bio-Rad Laboratories, Inc.
3 boulevard raymond poincare'
marnes-la-coquette 92430
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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