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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device method, nephelometric, immunoglobulins (g, a, m)
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Product CodeCFN
Regulation Number 866.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER INC.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE
  SUBSTANTIALLY EQUIVALENT 5
THE BINDING SITE GROUP LTD
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Adverse Event Without Identified Device or Use Problem 3
High Test Results 2
Low Test Results 2
Total Device Problems 7

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. III Mar-17-2015
2 The Binding Site Group, Ltd. II Dec-13-2018
3 The Binding Site Group, Ltd. II Nov-17-2018
4 The Binding Site Group, Ltd. III Jul-27-2017
5 The Binding Site Group, Ltd. II Jan-23-2017

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