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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiac c-reactive protein, antigen, antiserum, and control
Definition In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
Product CodeNQD
Regulation Number 866.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
SENTINEL CH. SPA
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1
2021 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 2 2
Non Reproducible Results 2 2
Incorrect Or Inadequate 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 3 3
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Jan-24-2017
2 Siemens Healthcare Diagnostics Inc II Jan-07-2016
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