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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device system, test, c-reactive protein
Regulation Description C-reactive protein immunological test system.
Product CodeDCN
Regulation Number 866.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTIC PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 4 4
2024 5 5
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 8 8
Non Reproducible Results 6 6
Incorrect Measurement 3 3
Incorrect, Inadequate or Imprecise Result or Readings 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Dec-17-2020
2 Siemens Healthcare Diagnostics, Inc. II Apr-10-2025
3 The Binding Site Group, Ltd. II Mar-31-2020
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