Hysen Drug Test Cups

Basic Information

• Brand Name: Hysen Drug Test Cups
• Primary DI: 10850076289055
• Version / Model: HDRC-187-011
• Catalog Number: HDRC-187-011
• Company Name: HYSEN INC.
• Labeler DUNS: 136301242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2026-03-18
• Public Version: 1
• Public Version Date: 2026-03-26
• Public Version Status: New
• Public Device Record Key: 35c608b5-b6ee-42ad-93c2-2f620f84b2dd
• Distribution End Date: 2036-03-17

Device Description

Hysen Drug Test Cups COC300/AMP1000/MET1000/THC50/MTD300/MOP300/OXY100/BUP10

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	862.3100	2
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	862.3870	2
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	862.3620	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	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	20850076289052	GS1	Case	8	In Commercial Distribution	2036-03-17
Primary	10850076289055	GS1
Unit of Use	00850076289058	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius