Easy@Home Multi-Drug Screen Test (5 tests/kit)

Basic Information

• Brand Name: Easy@Home Multi-Drug Screen Test (5 tests/kit)
• Primary DI: 00810038630625
• Version / Model: EDOAP-3104
• Company Name: EASY HEALTHCARE CORPORATION
• Labeler DUNS: 080278407
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-02-17
• Public Version: 3
• Public Version Date: 2023-11-10
• Public Version Status: Update
• Public Device Record Key: 0b844615-0b63-4422-828c-350d0fc5cc7f

Device Description

5 tests per kit;10-Panel Dip Card; AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA

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
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	862.3170	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2
LAF	Gas 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
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	10810038630622	GS1	Carton	36	In Commercial Distribution
Primary	00810038630625	GS1
Unit of Use	30810038630626	GS1