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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
Product CodeMJH
Regulation Number 866.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
SSI DIAGNOSTICA A/S
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 2 2
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Clark Laboratories, Inc. II Dec-15-2021
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