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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 19 19
False Negative Result 16 16
No Apparent Adverse Event 16 16
Device Markings/Labelling Problem 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Contamination 2 2
Improper or Incorrect Procedure or Method 2 2
Product Quality Problem 2 2
Non Reproducible Results 1 1
Activation, Positioning or Separation Problem 1 1
Erratic Results 1 1
Insufficient Information 1 1
Use of Device Problem 1 1
Off-Label Use 1 1
Output Problem 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
Unspecified Infection 14 14
Viral Infection 5 5
Test Result 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Insufficient Information 1 1
Eye Injury 1 1
Sexually Transmitted Infection 1 1
No Consequences Or Impact To Patient 1 1

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