EZ-SHIGELLA One-Step Shigella species Rapid Test

FDA UDI

Class II (US FDA UDI)

by Biomerica, Inc.

Identity

Trade Name: EZ-SHIGELLA One-Step Shigella species Rapid Test FDA UDI
Generic Name: Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 1009-15 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00083059100952 FDA UDI
FDA Product Code: GNB FDA UDI
GMDN Term: Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

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

EZ-SHIGELLA One-Step Shigella species Rapid Test by Biomerica, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biomerica, Inc.

Sources (1)

FDA UDI 561f3fec-ea61-4b45-a20a-33e084c52ff5 34 fields · synced Jun 6, 2026