ACCU NEWS Multi-Drug Screen Test

Basic Information

• Brand Name: ACCU NEWS Multi-Drug Screen Test
• Primary DI: 00850042559024
• Version / Model: Multi-panel
• Company Name: CORETESTS, INC.
• Labeler DUNS: 036440919
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-31
• Public Version: 3
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 7717c84a-f288-4094-8167-9c3efec58ad7

Device Description

5 pcs/box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55562	Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active
61891	6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 6-acetyl morphine in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active
42633	Amphetamine/methamphetamine group IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple drugs belonging to the amphetamine and/or methamphetamine group(s) in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active
55496	Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of a specific methamphetamine in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active
55550	Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850042559021	GS1		5	In Commercial Distribution
Primary	00850042559024	GS1

Premarket Submissions

Submission Number	Supplement Number
K152590	000