Enzyme Immunoassay, Barbiturate

Device Code: 6032

Product Code(s): DIS

Device Classification Information

• Device Type ID: 6032
• Device Name: Enzyme Immunoassay, Barbiturate
• Regulation Description: Barbiturate 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: 862.3150 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DIS
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 6032
• Device: Enzyme Immunoassay, Barbiturate
• Product Code: DIS
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Barbiturate Test System.
• CFR Regulation Number: 862.3150 [🔎]

Premarket Reviews
Manufacturer	Decision
CO-INNOVATION BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GENPRIME, INC
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU WONDFO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEALGEN SCIENTIFIC LLC
	SUBSTANTIALLY EQUIVALENT	1
IMMUNALYSIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Guangzhou Wondfo Biotech Co., Ltd.	II	Aug-12-2018
2	OraSure Technologies, Inc.	III	Dec-08-2016

TPLC Last Update: 2019-04-02 21:16:18