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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 1
ARK DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASSURE TECH. (HANGZHOU) CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHEMTRON BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CO-INNOVATION BIOTECH CO ., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU ALLTEST BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU LAIHE BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALGEN SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMMUNALYSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
LIN-ZHI INTERNATIONAL, , INC.
  SUBSTANTIALLY EQUIVALENT 4
LMMUNALYSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MICROGENICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PSYCHEMEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
VIVACHEK BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XENTA BIOMEDICAL SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 1 1
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 3 3
Compatibility Problem 1 1
Defective Device 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 3 3
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Apr-20-2020
2 Carolina Liquid Chemistries Corp II Apr-17-2020
3 Ortho-Clinical Diagnostics, Inc. II Jul-02-2025
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