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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, test, c-reactive protein
Product CodeDCN
Regulation Number 866.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
MESO SCALE DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTIC PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP LTD
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 8 8
2021 1 1
2022 1 1
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 7 7
Low Test Results 7 7
Non Reproducible Results 4 4
Incorrect Measurement 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Dec-17-2020
2 The Binding Site Group, Ltd. II Mar-31-2020
3 The Binding Site Group, Ltd. II Dec-12-2019
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