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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device helicobacter pylori
Product CodeLYR
Regulation Number 866.3110
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
PANION & BF BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Immunostics, Inc. II Jan-10-2024
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