QuikScreen

Basic Information

• Brand Name: QuikScreen
• Primary DI: 00748349000168
• Version / Model: 60825
• Company Name: SYNTRON BIORESEARCH, INC.
• Labeler DUNS: 174517060
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-19
• Public Version: 5
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 1aab4c37-b3fb-49a7-b155-1d4a1a074f63

Device Description

QuikScreen Multi 8 Drug Cup Test - AMP 1000, BUP 10, BZD 300, COC 300, MAD 300, OPI 300, OXY 100, THC 50

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55463	Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of drug and/or toxicology screen adulteration of a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid spectrophotometry method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10748349000165	GS1	Kit Box	25	In Commercial Distribution
Primary	00748349000168	GS1
Package	20748349000162	GS1	Shipper Box	4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K071489	000
K122064	000
K130275	000