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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 NameACS:180/ADVIA CENTAUR AFP IMMUNOASSAY
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Nameafp immunoassay
ApplicantBAYER DIAGNOSTICS CORP.
PMA NumberP930036
Supplement NumberS002
Date Received01/16/2002
Decision Date02/12/2002
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of purified mouse afp clone ml355-7g12. 2a6. 5c4 antibody in the production of the bayer acs:180 and advia centaur afp solid phase.
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