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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drug mixture control materials
Regulation Description Clinical toxicology control material.
Product CodeDIF
Regulation Number 862.3280
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 33
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
FISHER
  SUBSTANTIALLY EQUIVALENT 1
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 16

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. III Oct-23-2013
2 Lin-Zhi International Inc II Jan-23-2012

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