QuikScreen 7+4

Basic Information

• Brand Name: QuikScreen 7+4
• Primary DI: 00748349000724
• Version / Model: 65732-7
• Company Name: SYNTRON BIORESEARCH, INC.
• Labeler DUNS: 174517060
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-28
• Public Version: 3
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 81625b7d-e3b5-4572-888a-dd1af3495a64
• Distribution End Date: 2020-09-28

Device Description

QuikScreen 7+4 AMP 500, COC 150, MDMA 500, MET 500, OPI 2000, OXY 100, THC50 + PH/CRE/SG/NBP Cat. 65732-7

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
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	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
Primary	00748349000724	GS1
Package	10748349000721	GS1	Kit Box	25	Not in Commercial Distribution	2020-09-28

Premarket Submissions

Submission Number	Supplement Number
K071489	000
K130275	000