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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, benzodiazepine
Product CodeJXM
Regulation Number 862.3170
Device Class 2


Premarket Reviews
ManufacturerDecision
MICROGENICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2021 1 1
2023 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 5 5
False Positive Result 2 2
Non Reproducible Results 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
High Test Results 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 OraSure Technologies, Inc. III Aug-24-2020
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