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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fibrinogen and fibrin split products, antigen, antiserum, control
Product CodeDAP
Regulation Number 864.7320
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. I Jul-06-2012
2 BioMerieux SA II Aug-14-2014
3 Siemens Healthcare Diagnostics Inc II Jan-07-2016
4 Siemens Healthcare Diagnostics, Inc. III Aug-28-2012
5 bioMerieux, Inc. II Dec-28-2021
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