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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, radioallergosorbent (rast) immunological
Product CodeDHB
Regulation Number 866.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYCOR BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 3
  1.  K191510  Noveos Immunoanalyzer System, Noveos Specific IgE ...
  2.  K200825  NOVEOS Specific IgE (sIgE), Capture Reagent Cat Da ...
  3.  K220162  Noveos Immunoanalyzer System, Noveos Specific IgE ...
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 4 4
2021 7 7
2022 1 1
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 11 11
Low Test Results 8 8
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Hycor Biomedical LLC II Oct-29-2019
2 Phadia Ab II Aug-26-2019
3 Siemens Healthcare Diagnostics, Inc. II Dec-15-2022
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