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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device legionella, spp., elisa
Regulation Description Haemophilus spp. serological reagents.
Product CodeMJH
Regulation Number 866.3300
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2023 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 1 1
Contamination of Device Ingredient or Reagent 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Clark Laboratories, Inc. II Dec-15-2021
2 Trinity Biotech USA II Aug-12-2025
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