GUDIDData
eudamed_udi Primary ID: 00811403012589

Reference solution (UDI 00811403012589)

Manufactured by Diamond Diagnostics Inc

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Reference solution - Primary ID 00811403012589

Device Regulatory Overview

The Reference solution (Model/Catalog Number: BM-450042D) is a medical device manufactured by Diamond Diagnostics Inc. This product is indexed under FDA Product Code / Category Classification W0101050399 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
BM-450042D
Product Code / EMDN
W0101050399
Device Name
ISE Internal Reference HT911
Database Sync Date
2026-08-09 16:29:21

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 Reference solution?

The registered manufacturer of record for Reference solution is Diamond Diagnostics Inc.

What is the Primary UDI-DI identifier for Reference solution?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00811403012589.

What classification code is assigned to this device?

This device is registered under product classification code W0101050399.

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