gudid Primary ID: 05p58-25

i-STAT (UDI 05p58-25)

Manufactured by ABBOTT POINT OF CARE INC.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The i-STAT (Model/Catalog Number: 05p58-25) is a medical device manufactured by ABBOTT POINT OF CARE INC.. This product is indexed under FDA Product Code / Category Classification DHA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 05p58-25
Product Code / EMDN: DHA
Device Name: CARTRIDGE, Total B-hCG
Database Sync Date: 2026-08-09 09:38:23

Full Regulatory Attributes

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{
    "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 i-STAT?

The registered manufacturer of record for i-STAT is ABBOTT POINT OF CARE INC..

What is the Primary UDI-DI identifier for i-STAT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05p58-25.

What classification code is assigned to this device?

This device is registered under product classification code DHA.

Similar Classification Devices (DHA)

Other Devices by ABBOTT POINT OF CARE INC.

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