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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device dna probe, nucleic acid amplification, chlamydia
Regulation Description Chlamydia serological reagents.
Product CodeMKZ
Regulation Number 866.3120
Device Class 1


Premarket Reviews
ManufacturerDecision
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 7 7
2021 9 9
2022 2 2
2023 4 4
2024 7 7
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 6 6
Break 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Insufficient Information 4 4
False Negative Result 3 3
Off-Label Use 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Use of Device Problem 2 2
Appropriate Term/Code Not Available 2 2
Volume Accuracy Problem 1 1
Material Integrity Problem 1 1
Difficult to Remove 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Foreign Body In Patient 4 4
Unspecified Gastrointestinal Problem 2 2
Obstruction/Occlusion 2 2
Chemical Exposure 2 2
Insufficient Information 2 2
Nasal Obstruction 2 2
Sedation 2 2
No Code Available 1 1
Anxiety 1 1
No Consequences Or Impact To Patient 1 1
Distress 1 1

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