GUDIDData
Bulk Audit Tool API Access
eudamed_udi Primary ID: 00884883003521

Unspecified Brand (UDI 00884883003521)

Manufactured by Microgenics Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 00884883003521

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: DBCL-S) is a medical device manufactured by Microgenics Corporation. This product is indexed under FDA Product Code / Category Classification W0101050205 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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Unlock Lot Data ($49)
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
DBCL-S
Product Code / EMDN
W0101050205
Device Name
MAS Diabetes Liquid Assayed Diabetes Control
Database Sync Date
2026-08-09 16:29:32

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

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Frequently Asked Questions

Who is the primary manufacturer of Unspecified Brand?

The registered manufacturer of record for Unspecified Brand is Microgenics Corporation.

What is the Primary UDI-DI identifier for Unspecified Brand?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00884883003521.

What classification code is assigned to this device?

This device is registered under product classification code W0101050205.

Similar Classification Devices (W0101050205)

Other Devices by Microgenics Corporation

Programmatic Export

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

JSON API Endpoint