GUDIDData
gudid Primary ID: 1

BioCode MDx 3000 Optical Calibration and Verification Kit (UDI 1)

Manufactured by APPLIED BIOCODE, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BioCode MDx 3000 Optical Calibration and Verification Kit - Primary ID 1

Device Regulatory Overview

The BioCode MDx 3000 Optical Calibration and Verification Kit (Model/Catalog Number: 1) is a medical device manufactured by APPLIED BIOCODE, INC.. This product is indexed under FDA Product Code / Category Classification within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
1
Product Code / EMDN
N/A
Device Name
Kit containing calibrators and controls for MDx 3000.
Database Sync Date
2026-08-09 09:49:37

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 BioCode MDx 3000 Optical Calibration and Verification Kit?

The registered manufacturer of record for BioCode MDx 3000 Optical Calibration and Verification Kit is APPLIED BIOCODE, INC..

What is the Primary UDI-DI identifier for BioCode MDx 3000 Optical Calibration and Verification Kit?

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

What classification code is assigned to this device?

This device is registered under product classification code .

Programmatic Export

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

JSON API Endpoint