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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
ALERE SAN DIEGO, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
BIOMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN, INC.
  SUBSTANTIALLY EQUIVALENT 1
GOLD STANDARD DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
MERIDIAN BIOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 3
PANION & BF BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
TECHLAB, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 2 2
2016 4 4
2017 1 1
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 6 6
Incorrect Or Inadequate Test Results 5 5
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Patient Involvement 3 3
No Clinical Signs, Symptoms or Conditions 2 2
No Information 1 1
No Code Available 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioCheck Inc II Mar-11-2011
2 Biomerieux Inc II Jan-04-2023
3 Calbiotech Inc II Mar-05-2010
4 Immunostics, Inc. II Jan-10-2024
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