Areta Multi-Drug Test Cup (5 tests kit)

Basic Information

• Brand Name: Areta Multi-Drug Test Cup (5 tests kit)
• Primary DI: 00855944007284
• Version / Model: ACDOA-6125B
• Catalog Number: ACDOA-6125B-5
• Company Name: EASY HEALTHCARE CORPORATION
• Labeler DUNS: 080278407
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-06-26
• Public Version: 7
• Public Version Date: 2022-07-25
• Public Version Status: Update
• Public Device Record Key: fc8ed9a3-1198-4cd8-abbc-1b4ae1d3ea9c

Device Description

Areta 12 Panel Drug Test Cup (5 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	862.3910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test 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	10855944007281	GS1	Carton	16	In Commercial Distribution
Primary	00855944007284	GS1
Unit of Use	30855944007285	GS1

Premarket Submissions

Submission Number	Supplement Number
K133968	000