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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
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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