HYSEN Fentanyl Rapid Test

Basic Information

• Brand Name: HYSEN Fentanyl Rapid Test
• Primary DI: 00850076289034
• Version / Model: HFYL-102A
• Catalog Number: HFYL-102A
• Company Name: HYSEN INC.
• Labeler DUNS: 136301242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2025-08-28
• Public Version: 1
• Public Version Date: 2025-09-05
• Public Version Status: New
• Public Device Record Key: b65c7d61-5a59-41b5-89db-5a820793263b

Device Description

HYSEN Fentanyl Rapid Test, 1 ng/mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: 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
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64153	Fentanyl 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 fentanyl 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	10850076289031	GS1		25	In Commercial Distribution
Primary	00850076289034	GS1
Unit of Use	20850076289038	GS1

Premarket Submissions

Submission Number	Supplement Number
K240351	000