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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent, borrelia serological reagent
Regulation Description Treponema pallidum treponemal test reagents.
Product CodeLSR
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN, INC.
  SUBSTANTIALLY EQUIVALENT 2
GOLD STANDARD DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 4
ID-FISH TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
INANOVATE, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIRAMED BIOTECH AG
  SUBSTANTIALLY EQUIVALENT 1
ZEUS SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 1 1
2023 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 7 7
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Patient Involvement 1 1
Unspecified Tissue Injury 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
2 bioMerieux, Inc. II Dec-28-2021
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