gudid Primary ID: 1501-15

EZ-GIARDIA One-Step Giardia Test (UDI 1501-15)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The EZ-GIARDIA One-Step Giardia Test (Model/Catalog Number: 1501-15) is a medical device manufactured by BIOMERICA, INC.. This product is indexed under FDA Product Code / Category Classification MHI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 1501-15
Product Code / EMDN: MHI
Device Name: The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualitative detection of Giardia antigens in human stool samples. The In Vitro test is intended for professional use only.
Database Sync Date: 2026-08-09 09:08:44

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of EZ-GIARDIA One-Step Giardia Test?

The registered manufacturer of record for EZ-GIARDIA One-Step Giardia Test is BIOMERICA, INC..

What is the Primary UDI-DI identifier for EZ-GIARDIA One-Step Giardia Test?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1501-15.

What classification code is assigned to this device?

This device is registered under product classification code MHI.

Similar Classification Devices (MHI)

Other Devices by BIOMERICA, INC.

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