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.

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

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.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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