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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dna probe, nucleic acid amplification, chlamydia
Product CodeMKZ
Regulation Number 866.3120
Device Class 1


Premarket Reviews
ManufacturerDecision
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 7 7
2021 9 9
2022 2 2
2023 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 5 5
False Negative Result 5 5
Adverse Event Without Identified Device or Use Problem 4 4
False Positive Result 4 4
Insufficient Information 4 4
Break 3 3
Off-Label Use 2 2
Use of Device Problem 2 2
Appropriate Term/Code Not Available 2 2
Material Integrity Problem 1 1
Volume Accuracy Problem 1 1
Fracture 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Foreign Body In Patient 4 4
No Consequences Or Impact To Patient 3 3
Nasal Obstruction 2 2
Obstruction/Occlusion 2 2
Sedation 2 2
Chemical Exposure 2 2
Complaint, Ill-Defined 1 1
No Code Available 1 1
Insufficient Information 1 1

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