Immunalysis Corporation

Basic Information

• Brand Name: Immunalysis Corporation
• Primary DI: 00840937111307
• Version / Model: 611OF-0500
• Catalog Number: 611OF-0500
• Company Name: IMMUNALYSIS CORPORATION
• Labeler DUNS: 080589004
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-01
• Public Version: 4
• Public Version Date: 2023-11-14
• Public Version Status: Update
• Public Device Record Key: 3bd4e6ab-1679-496f-b842-3e0870edc8e3

Device Description

Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay 500 mLKit

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: No
• Has Lot/Batch Number: No
• 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
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55496	Methamphetamine-specific 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 a specific methamphetamine 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	00840937111307	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius