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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 enzyme immunoassay, opiates
Regulation Description Opiate test system.
Product CodeDJG
Regulation Number 862.3650
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVIN BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU WONDFO BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANMEDICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALGEN SCIENTIFIC LLC
  SUBSTANTIALLY EQUIVALENT 1
IMMUNALYSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
LIN-ZHI INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
OMEGA LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PSYCHEMEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI CHEMTRON BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2015 3 3
2016 2 2
2017 1 1
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
False Positive Result 3 3
False Negative Result 2 2
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 5 5
Death 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ameditech Inc III Dec-17-2019
2 Beckman Coulter Inc. II Apr-20-2020
3 Carolina Liquid Chemistries Corp II Apr-17-2020
4 Siemens Healthcare Diagnostics, Inc. III May-10-2018
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