OSOM Mono 25 Test Kit

Basic Information

• Brand Name: OSOM Mono 25 Test Kit
• Primary DI: 00742860001451
• Version / Model: 145
• Catalog Number: 145
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Labeler DUNS: 966812344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: af951767-5688-451b-b923-3a8b01826a6c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
KTN	SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS	Immunology	866.5640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
49689	Epstein-Barr virus (EBV) heterophile antibody 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 heterophile antibodies produced in response to Epstein-Barr virus (EBV) 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 to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. 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
Primary	00742860001451	GS1
Unit of Use	10742860001458	GS1