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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
Product CodeDGC
Regulation Number 866.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOKIT, S.A.
  SUBSTANTIALLY EQUIVALENT 1
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2016 2 2
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 2 2
High Test Results 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Miscarriage 1 1
Venipuncture 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Randox Laboratories Ltd. II Oct-06-2016
2 Siemens Medical Solutions Diagnostics II May-26-2009
3 Tosoh Bioscience Inc II Jun-05-2018
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