gudid Primary ID: R3.1

BACT/ALERT (UDI R3.1)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The BACT/ALERT (Model/Catalog Number: R3.1) is a medical device manufactured by BIOMERIEUX , INC.. This product is indexed under FDA Product Code / Category Classification MDB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: R3.1
Product Code / EMDN: MDB
Device Name: R3.1 SW/FW for BACT/ALERT VIRTUO
Database Sync Date: 2026-08-09 09:46:56

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 BACT/ALERT?

The registered manufacturer of record for BACT/ALERT is BIOMERIEUX , INC..

What is the Primary UDI-DI identifier for BACT/ALERT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is R3.1.

What classification code is assigned to this device?

This device is registered under product classification code MDB.

Similar Classification Devices (MDB)

Other Devices by BIOMERIEUX , INC.

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