GUDIDData
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gudid Primary ID: 10015658

CEDIA Buprenorphine Assay (UDI 10015658)

Manufactured by Microgenics Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CEDIA Buprenorphine Assay - Primary ID 10015658

Device Regulatory Overview

The CEDIA Buprenorphine Assay (Model/Catalog Number: 10015658) is a medical device manufactured by Microgenics Corporation. This product is indexed under FDA Product Code / Category Classification DJG 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 →

QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS C...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-1563-2013 View Full Alert →

Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporatio...

🔒 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
10015658
Product Code / EMDN
DJG
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 Buprenorphine Assay?

The registered manufacturer of record for CEDIA Buprenorphine Assay is Microgenics Corporation.

What is the Primary UDI-DI identifier for CEDIA Buprenorphine Assay?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10015658.

What classification code is assigned to this device?

This device is registered under product classification code DJG.

Similar Classification Devices (DJG)

Other Devices by Microgenics Corporation

Programmatic Export

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

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