GenaCheck 12-Drug Rapid Self-Test Kit

Basic Information

• Brand Name: GenaCheck 12-Drug Rapid Self-Test Kit
• Primary DI: 00810143620061
• Version / Model: RA9-E01902
• Company Name: Genabio Diagnostics Inc.
• Labeler DUNS: 118586095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-10-06
• Public Version: 1
• Public Version Date: 2023-10-16
• Public Version Status: New
• Public Device Record Key: 4dc37fea-34d8-4edf-8f82-01375d0558b9

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	862.3250	2
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	862.3150	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	862.3700	2
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	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
Unit of Use	10810143620068	GS1
Primary	00810143620061	GS1