GUDIDData
gudid Primary ID: 725141

Aptiva APS IgM Calibrators (UDI 725141)

Manufactured by INOVA DIAGNOSTICS, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Aptiva APS IgM Calibrators - Primary ID 725141

Device Regulatory Overview

The Aptiva APS IgM Calibrators (Model/Catalog Number: 725141) is a medical device manufactured by INOVA DIAGNOSTICS, INC.. This product is indexed under FDA Product Code / Category Classification JIX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
725141
Product Code / EMDN
JIX
Device Name
1.Aptiva APS IgM Calibrator 1 (2x0.3mL)2. Aptiva APS IgM Calibrator 2 (2x0.3mL)3. Aptiva APS IgM Calibrator 3 (2x0.3mL)
Database Sync Date
2026-08-09 09:10:49

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 Aptiva APS IgM Calibrators?

The registered manufacturer of record for Aptiva APS IgM Calibrators is INOVA DIAGNOSTICS, INC..

What is the Primary UDI-DI identifier for Aptiva APS IgM Calibrators?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 725141.

What classification code is assigned to this device?

This device is registered under product classification code JIX.

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