EZ-SHIGELLA One-Step Shigella species Rapid Test

Basic Information

• Brand Name: EZ-SHIGELLA One-Step Shigella species Rapid Test
• Primary DI: 00083059100952
• Version / Model: 1009-15
• Company Name: BIOMERICA, INC.
• Labeler DUNS: 067647321
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-01
• Public Version: 1
• Public Version Date: 2020-07-09
• Public Version Status: New
• Public Device Record Key: 561f3fec-ea61-4b45-a20a-33e084c52ff5

Device Description

The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
GNB	Antisera, All Types, Shigella Spp.	Microbiology	866.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51604	Multiple Shigella species verotoxin 1 & 2 antigen 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 verotoxin 1 and/or verotoxin 2 antigens from one or multiple species of Shigella bacteria 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	00083059100952	GS1

Customer Contacts

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