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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device susceptibility test plate, antifungal
Definition The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.
Product CodeNGZ
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
AB BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 6
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 4
TREK DIAGNOSTIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TREK DIAGNOSTIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 9 9
2017 16 16
2018 10 10
2021 8 8
2022 3 3
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Incorrect Or Inadequate Test Results 22 22
Low Test Results 6 6
Tear, Rip or Hole in Device Packaging 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 22 22
No Clinical Signs, Symptoms or Conditions 14 14
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 3 3
Death 1 1
Septic Shock 1 1
No Code Available 1 1
Cancer 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Biomerieux Inc II May-22-2017
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