SEFRIA™

Basic Information

• Brand Name: SEFRIA™
• Primary DI: 00840937112120
• Version / Model: 612OF-0100
• Company Name: IMMUNALYSIS CORPORATION
• Labeler DUNS: 080589004
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-30
• Public Version: 2
• Public Version Date: 2023-11-14
• Public Version Status: Update
• Public Device Record Key: 7c2d214c-918f-4a6f-a19e-21e51f578581

Device Description

SEFRIA™ Cocaine/Benzoylecgonine Oral Fluid Kit 100

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: Yes
• Has Serial Number: Yes
• 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
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55562	Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840937112120	GS1

Customer Contacts

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