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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device influenza a and influenza b multiplex nucleic acid assay
Definition An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.
Product CodeOZE
Regulation Number 866.3980
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALERE SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTER FOR DISEASE CONTROL AND PREVENTION (CDC)
  SUBSTANTIALLY EQUIVALENT 1
CENTERS FOR DISEASE CONTROL AND PREVENTION
  SUBSTANTIALLY EQUIVALENT 6
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
  SUBSTANTIALLY EQUIVALENT 3
INDEVR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MESA BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 2
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
False Positive Result 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Luminex Corporation II Aug-15-2019
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