HYSEN Fentanyl Rapid Test HFYL-102A

GUDID 10850076289031

HYSEN Fentanyl Rapid Test, 1 ng/mL

HYSEN INC.

Fentanyl IVD, kit, rapid ICT, clinical

• Primary Device ID: 10850076289031
• NIH Device Record Key: b65c7d61-5a59-41b5-89db-5a820793263b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYSEN Fentanyl Rapid Test
• Version Model Number: HFYL-102A
• Catalog Number: HFYL-102A
• Company DUNS: 136301242
• Company Name: HYSEN INC.
• Device Count: 40
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850076289034 [Primary]
GS1	10850076289031 [Package]; Contains: 00850076289034; Package: [25 Units]; In Commercial Distribution
GS1	20850076289038 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240351

FDA Product Code

• NGL: Test, Opiates, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-05
• Device Publish Date: 2025-08-28

Devices Manufactured by HYSEN INC.

• 10850076289024 - HYSEN Multi-Panel Drug Test Dip Card: 2025-09-05 HYSEN Multi-Panel Drug Test Dip Card, PCP /25, AMP/1000, BAR/300, BUP/10, BZO/300, COC/300, MDMA/500, MET/1000, MTD/300, OPI/300
• 10850076289031 - HYSEN Fentanyl Rapid Test: 2025-09-05HYSEN Fentanyl Rapid Test, 1 ng/mL
• 10850076289031 - HYSEN Fentanyl Rapid Test: 2025-09-05 HYSEN Fentanyl Rapid Test, 1 ng/mL
• 10850076289048 - HYSEN Multiple Drugs Test Cup: 2025-09-05 HYSEN Multiple Drugs Test Cup, AMP/500, BAR/300, BUP/10, BZO/300, COC/150, EDDP/300, FEN/1, MDMA/500, MET/500, MOR/300, NFYL/5,
• 00850076289003 - Hysen Drug Test Cups: 2025-08-12 Hysen Drug Test Cups AMP1000/BAR300/BUP10/BZO300/COC300/MET1000/MDMA500/MTD300/OPI2000/OXY100/PCP25/PPX300/TCA1000/THC50+S.G./CR
• 00850076289010 - Hysen Drug Test Cards: 2025-08-12 Hysen Drug Test Cards AMP1000/BAR300/BUP10/BZO300/COC300/MET1000/MDMA500/MTD300/MOP300/OXY100/PCP25/THC50