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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagents, clostridium difficile toxin
Product CodeLLH
Regulation Number 866.2660
Device Class 1


Premarket Reviews
ManufacturerDecision
FIRST LIGHT DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2 2
Nonstandard Device 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Dec-28-2021
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