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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ige, antigen, antiserum, control
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Product CodeDGC
Regulation Number 866.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 6
PHARMACIA & UPJOHN CO.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Mechanical issue 5
No Known Device Problem 4
Incorrect or inadequate result 1
Incorrect or inadequate test results 1
High test results 1
Contamination of device ingredient or reagent 1
Total Device Problems 13

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 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Medical Solutions Diagnostics II May-26-2009

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