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gudid Primary ID: 10014951

CEDIA Methamphetamine OFT Cutoff Calibrator (UDI 10014951)

Manufactured by Microgenics Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CEDIA Methamphetamine OFT Cutoff Calibrator - Primary ID 10014951

Device Regulatory Overview

The CEDIA Methamphetamine OFT Cutoff Calibrator (Model/Catalog Number: 10014951) is a medical device manufactured by Microgenics Corporation. This product is indexed under FDA Product Code / Category Classification DLJ 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-1284-2022 View Full Alert →

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🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1563-2013 View Full Alert →

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🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0379-2013 View Full Alert →

Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed con...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
10014951
Product Code / EMDN
DLJ
Device Name
Database Sync Date
2026-08-09 09:45:39

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 CEDIA Methamphetamine OFT Cutoff Calibrator?

The registered manufacturer of record for CEDIA Methamphetamine OFT Cutoff Calibrator is Microgenics Corporation.

What is the Primary UDI-DI identifier for CEDIA Methamphetamine OFT Cutoff Calibrator?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10014951.

What classification code is assigned to this device?

This device is registered under product classification code DLJ.

Similar Classification Devices (DLJ)

Other Devices by Microgenics Corporation

Programmatic Export

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