Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 11 11
2021 16 16
2022 16 16
2023 6 6
2024 5 5
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 28 28
Low Test Results 18 18
No Apparent Adverse Event 6 6
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Non Reproducible Results 3 3
High Readings 2 2
Mechanical Problem 1 1
Imprecision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
No Known Impact Or Consequence To Patient 9 9
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc II Sep-03-2021
2 Siemens Healthcare Diagnostics, Inc. II Aug-29-2022
-
-