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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
Product CodeDJG
Regulation Number 862.3650
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVIN BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARK DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ASSURE TECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHEMTRON BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ALLTEST BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU LAIHE BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMMUNALYSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED)
  SUBSTANTIALLY EQUIVALENT 1
LIN-ZHI INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
LMMUNALYSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MICROGENICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
PSYCHEMEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
RANDOX LABORATORIES LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI ACCURATURE DIAGNOSTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BIOEASY BIOTECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SUPERBIO TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XENTA BIOMEDICAL SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 2 2
Product Quality Problem 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
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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