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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dna-reagents, neisseria
Product CodeLSL
Regulation Number 866.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 14 14
2020 3 3
2021 4 4
2022 12 12
2023 23 23
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 18 18
No Apparent Adverse Event 16 16
False Negative Result 12 12
Device Markings/Labelling Problem 3 3
Contamination 2 2
Product Quality Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Improper or Incorrect Procedure or Method 2 2
Activation, Positioning or Separation Problem 1 1
Use of Device Problem 1 1
Off-Label Use 1 1
Installation-Related Problem 1 1
Output Problem 1 1
Insufficient Information 1 1
Non Reproducible Results 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
Unspecified Infection 14 14
Viral Infection 5 5
Test Result 2 2
Sexually Transmitted Infection 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Consequences Or Impact To Patient 1 1
Eye Injury 1 1

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