OSOM Ultra Strep A 50 Test Kit

Basic Information

• Brand Name: OSOM Ultra Strep A 50 Test Kit
• Primary DI: 00742860001499
• Version / Model: 149
• Catalog Number: 149
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Labeler DUNS: 966812344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: ffb498a6-8275-47bf-903d-2b7ffc8af384

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
GTY	ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51707	Beta-haemolytic Group A Streptococcus antigen 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 antigens from Group A beta-haemolytic Streptococcus bacteria 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. 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	00742860001499	GS1
Unit of Use	10742860001472	GS1