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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
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
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 8 8
Low Test Results 6 6
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
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