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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device urinary homocystine (nonquantitative) test system
Regulation Description Urinary homocystine (nonquantitative) test system.
Product CodeLPS
Regulation Number 862.1377
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 3
Total Device Problems 3

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 1 0 0 1 2 1 2 2
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Axis-Shield Diagnostics, Ltd. II Jul-01-2015
2 CSL Behring GmbH II Jul-19-2016
3 Catch Incorporated II Jan-27-2012
4 Catch Incorporated II Jan-06-2009
5 Medtest Holdings, Inc. II Jun-28-2016
6 Ortho-Clinical Diagnostics II Jun-19-2013
7 Roche Diagnostics Operations, Inc. II May-15-2015
8 Siemens Healthcare Diagnostics, Inc II Jul-02-2014
9 Siemens Healthcare Diagnostics, Inc. II Dec-19-2013
10 Siemens Healthcare Diagnostics, Inc. III Nov-06-2012

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