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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, natriuretic peptide
Regulation Description B-type natriuretic peptide test system.
Product CodeNBC
Regulation Number 862.1117
Device Class 2


Premarket Reviews
ManufacturerDecision
AXIS-SHIELD DIAGNOSTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 4 4
2023 26 27
2024 14 15
2025 17 17
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 52 53
Non Reproducible Results 24 25
High Test Results 16 17
Incorrect, Inadequate or Imprecise Result or Readings 4 5
Low Readings 3 4
High Readings 2 2
Insufficient Device Problem Information 2 3
Improper or Incorrect Procedure or Method 1 1
False Negative Result 1 1
Incorrect Measurement 1 1
False Positive Result 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70 72
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Insufficient Information 2 2

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