GUDIDData
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eudamed_udi Primary ID: 00630414027982

Emit II Plus Oxycodone Negative Control 300 (UDI 00630414027982)

Manufactured by Siemens Healthcare Diagnostics Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Emit II Plus Oxycodone Negative Control 300 - Primary ID 00630414027982

Device Regulatory Overview

The Emit II Plus Oxycodone Negative Control 300 (Model/Catalog Number: 10720811) is a medical device manufactured by Siemens Healthcare Diagnostics Inc.. This product is indexed under FDA Product Code / Category Classification W0102152001 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2087-2016 View Full Alert →

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ID: Z-2058-2014 View Full Alert →

Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics...

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ID: Z-0459-2016 View Full Alert →

Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with ...

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Technical Specifications

Model Number
10720811
Product Code / EMDN
W0102152001
Device Name
IVDR_67_GLA_DUB-C_B_REAG_Oxycodone Pos and Neg Controls
Database Sync Date
2026-08-09 18:06:01

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 Emit II Plus Oxycodone Negative Control 300?

The registered manufacturer of record for Emit II Plus Oxycodone Negative Control 300 is Siemens Healthcare Diagnostics Inc..

What is the Primary UDI-DI identifier for Emit II Plus Oxycodone Negative Control 300?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00630414027982.

What classification code is assigned to this device?

This device is registered under product classification code W0102152001.

Similar Classification Devices (W0102152001)

Other Devices by Siemens Healthcare Diagnostics Inc.

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