gudid Primary ID: D12.11.1-1VA

Rapid Response (UDI D12.11.1-1VA)

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: D12.11.1-1VA) is a medical device manufactured by BTNX Inc. This product is indexed under FDA Product Code / Category Classification NGL within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: D12.11.1-1VA
Product Code / EMDN: NGL
Device Name: One Step 12 Panel DOA Cup + Adulteration Test (12.11.1) - MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi
Database Sync Date: 2026-08-09 09:19:11

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 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 D12.11.1-1VA.

What classification code is assigned to this device?

This device is registered under product classification code NGL.

Similar Classification Devices (NGL)

Other Devices by BTNX Inc

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