Rapid Response (UDI U120)

Manufactured by BTNX Inc

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Rapid Response (Model/Catalog Number: U120) is a medical device manufactured by BTNX Inc. This product is indexed under FDA Product Code / Category Classification LJX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: U120
Product Code / EMDN: LJX
Device Name: Urine Analyzer 120
Database Sync Date: 2026-08-09 09:19:11

Full Regulatory Attributes

🔒 Token Gated

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

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of Rapid Response?

The registered manufacturer of record for Rapid Response is BTNX Inc.

What is the Primary UDI-DI identifier for Rapid Response?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is U120.

What classification code is assigned to this device?

This device is registered under product classification code LJX.

Similar Classification Devices (LJX)

Other Devices by BTNX Inc

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint