GUDIDData
gudid Primary ID: 10015654

DRI pH-Detect Test (UDI 10015654)

Manufactured by Microgenics Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DRI pH-Detect Test - Primary ID 10015654

Device Regulatory Overview

The DRI pH-Detect Test (Model/Catalog Number: 10015654) is a medical device manufactured by Microgenics Corporation. This product is indexed under FDA Product Code / Category Classification JQY 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
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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
10015654
Product Code / EMDN
JQY
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 DRI pH-Detect Test?

The registered manufacturer of record for DRI pH-Detect Test is Microgenics Corporation.

What is the Primary UDI-DI identifier for DRI pH-Detect Test?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10015654.

What classification code is assigned to this device?

This device is registered under product classification code JQY.

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