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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, immunological, antigen, tumor
Regulation Description Tumor-associated antigen immunological test system.
Product CodeMOI
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 5 5
2017 7 7
2018 1 1
2019 5 5
2020 11 11
2021 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 17 17
No Apparent Adverse Event 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Low Test Results 7 7
High Readings 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 25 25
No Clinical Signs, Symptoms or Conditions 15 15
No Consequences Or Impact To Patient 2 2
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II May-12-2017
2 Siemens Healthcare Diagnostics, Inc II Sep-03-2021
3 Siemens Healthcare Diagnostics, Inc II Apr-06-2017
4 Siemens Healthcare Diagnostics, Inc. II May-04-2018
5 Tosoh Bioscience Inc II Jun-05-2018
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