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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Miscarriage 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Randox Laboratories Ltd. II Oct-06-2016
2 Tosoh Bioscience Inc II Jun-05-2018
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