GUDIDData
gudid Primary ID: BACT/ALERT FA PLUS

BACT/ALERT FA PLUS (UDI BACT/ALERT FA PLUS)

Manufactured by BIOMERIEUX , INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BACT/ALERT FA PLUS - Primary ID BACT/ALERT FA PLUS

Device Regulatory Overview

The BACT/ALERT FA PLUS (Model/Catalog Number: BACT/ALERT FA PLUS) 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
BACT/ALERT FA PLUS
Product Code / EMDN
MDB
Device Name
The BACT/ALERT FA Plus Culture Bottles are used for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Database Sync Date
2026-08-09 09:46:56

Full Regulatory Attributes

🔒 Token Gated
{
    "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 FA PLUS?

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

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

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BACT/ALERT FA PLUS.

What classification code is assigned to this device?

This device is registered under product classification code MDB.

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