gudid Primary ID: 7069

Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] (UDI 7069)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] (Model/Catalog Number: 7069) 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: 7069
Product Code / EMDN: MHI
Device Name: The Biomerica Giardia ELISA is intended for the qualitative detection of Giardia antigen in fecal specimens. This assay is intended for research 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 Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]?

The registered manufacturer of record for Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] is BIOMERICA, INC..

What is the Primary UDI-DI identifier for Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 7069.

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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