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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
Regulation Description Neisseria spp. direct serological test reagents.
Product CodeLSL
Regulation Number 866.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 4 4
2022 11 11
2023 19 19
2024 18 18
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 28 28
False Negative Result 6 6
Erratic Results 5 5
Device Markings/Labelling Problem 3 3
No Apparent Adverse Event 3 3
Contamination 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Off-Label Use 1 1
Output Problem 1 1
Non Reproducible Results 1 1
Insufficient Information 1 1
Use of Device Problem 1 1
Installation-Related Problem 1 1
Appropriate Term/Code Not Available 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
Insufficient Information 3 3
Unspecified Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Test Result 1 1
Viral Infection 1 1
Eye Injury 1 1
Sexually Transmitted Infection 1 1
No Consequences Or Impact To Patient 1 1

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