Enzyme Immunoassay, Opiates

Device Code: 6043

Product Code(s): DJG

Device Classification Information

• Device Type ID: 6043
• Device Name: Enzyme Immunoassay, Opiates
• Regulation Description: Opiate Test System.
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.3650 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DJG
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 6043
• Device: Enzyme Immunoassay, Opiates
• Product Code: DJG
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Opiate Test System.
• CFR Regulation Number: 862.3650 [🔎]

Premarket Reviews
Manufacturer	Decision
ADVIN BIOTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOPHOR DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CO-INNOVATION BIOTECH CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU WONDFO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
HANMEDICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEALGEN SCIENTIFIC LLC
	SUBSTANTIALLY EQUIVALENT	2
IMMUNALYSIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
LIN-ZHI INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
OMEGA LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRINCETON BIOMEDITECH CORP.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI CHEMTRON BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SIEMENS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
THERMO FISHER SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Lin-Zhi International Inc	III	Mar-21-2014
2	Siemens Healthcare Diagnostics, Inc.	III	May-10-2018

TPLC Last Update: 2019-04-02 21:16:27