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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device devices detecting influenza a, b, and c virus antigens
Regulation Description Influenza virus antigen detection test system.
Definition An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
Product CodePSZ
Regulation Number 866.3328
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS BIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 2
SEKISUI DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 41 41
2022 10 10
2023 12 12
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 37 37
Incorrect, Inadequate or Imprecise Result or Readings 31 31
False Negative Result 5 5
Inaccurate Information 2 2
Device Markings/Labelling Problem 1 1
Material Integrity Problem 1 1
Shipping Damage or Problem 1 1
Device Ingredient or Reagent Problem 1 1
Component Missing 1 1
Fluid/Blood Leak 1 1
Detachment of Device or Device Component 1 1
Crack 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 73
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 2 2
Death 1 1
Pain 1 1
Malaise 1 1
Sudden Cardiac Death 1 1
Chemical Exposure 1 1
Test Result 1 1
Chills 1 1
Pneumonia 1 1
Taste Disorder 1 1
Discomfort 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Feb-09-2022
2 Quidel Corporation II Nov-06-2020
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