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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigen, cf (including cf controls), respiratory syncytial virus
Regulation Description Respiratory syncytial virus serological reagents.
Product CodeGQG
Regulation Number 866.3480
Device Class 1


Premarket Reviews
ManufacturerDecision
NANO-DITECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 5 5
2022 3 3
2023 6 6
2024 2 2
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 8 8
False Negative Result 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Leak/Splash 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
Respiratory Arrest 1 1
Respiratory Tract Infection 1 1
No Consequences Or Impact To Patient 1 1

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