GUDIDData
gudid Primary ID: 2881

KETOSTIX (UDI 2881)

Manufactured by ASCENSIA DIABETES CARE US INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for KETOSTIX - Primary ID 2881

Device Regulatory Overview

The KETOSTIX (Model/Catalog Number: 2881) is a medical device manufactured by ASCENSIA DIABETES CARE US INC.. This product is indexed under FDA Product Code / Category Classification JIN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
2881
Product Code / EMDN
JIN
Device Name
Reagent Strips for Urinalysis: Ketone
Database Sync Date
2026-08-09 09:34:07

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 KETOSTIX?

The registered manufacturer of record for KETOSTIX is ASCENSIA DIABETES CARE US INC..

What is the Primary UDI-DI identifier for KETOSTIX?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 2881.

What classification code is assigned to this device?

This device is registered under product classification code JIN.

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