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.
EZ-SHIGELLA One-Step Shigella species Rapid Test - 1009-15
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GNB
Device Name: Antisera, All Types, Shigella Spp.
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.3660
Third Party Flag: N
Medical Specialty: MI
Device Identifiers
Device Id: 00083059100952
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
