EZ-SHIGELLA One-Step Shigella species Rapid Test

GUDID 00083059100952

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.

BIOMERICA, INC.

Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00083059100952
• NIH Device Record Key: 561f3fec-ea61-4b45-a20a-33e084c52ff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-SHIGELLA One-Step Shigella species Rapid Test
• Version Model Number: 1009-15
• Company DUNS: 067647321
• Company Name: BIOMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083059100952 [Primary]

FDA Product Code

• GNB: Antisera, All Types, Shigella Spp.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-09
• Device Publish Date: 2020-07-01

On-Brand Devices [EZ-SHIGELLA One-Step Shigella species Rapid Test]

• 08305901009155: The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of
• 00083059100952: The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of