GenaCheck™ Fentanyl Urine Home-Use Test Cassette

Basic Information

• Brand Name: GenaCheck™ Fentanyl Urine Home-Use Test Cassette
• Primary DI: 00860008954800
• Version / Model: RA9-E02525
• Catalog Number: RA9-E02501
• Company Name: Genabio Diagnostics Inc.
• Labeler DUNS: 118586095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-14
• Public Version: 2
• Public Version Date: 2024-08-13
• Public Version Status: Update
• Public Device Record Key: b7904151-c7f5-43b8-b4af-484b8a7d81f0

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: 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
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55461	Multiple drugs of abuse IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008954800	GS1
Package	10860008954807	GS1	Carton	108	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K233417	000