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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
Product CodeLSR
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 3
GOLD STANDARD DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 6
VIRAMED BIOTECH AG
  SUBSTANTIALLY EQUIVALENT 1
ZEUS SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
ZEUS SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 2
ZEUS SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 7 7
2021 4 4
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 17 17
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 8 8
No Clinical Signs, Symptoms or Conditions 6 6
No Patient Involvement 4 4
Disability 1 1
No Code Available 1 1

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