TPLC - Total Product Life Cycle

• Device: enzyme immunoassay, opiates
• Product Code: DJG
• Regulation Number: 862.3650
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADVIN BIOTECH, INC.
	SUBSTANTIALLY EQUIVALENT	2
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
IMMUNALYSIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LIN-ZHI INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
LMMUNALYSIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MICROGENICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
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
VIVACHEK BIOTECH (HANGZHOU) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XENTA BIOMEDICAL SCIENCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	1	1
2022	1	1
2024	1	1

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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	2	2
No Clinical Signs, Symptoms or Conditions	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