eudamed_udi Primary ID: 05415168013666

Antistreptolysin O (UDI 05415168013666)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Antistreptolysin O (Model/Catalog Number: ASLTX-L00/AU) is a medical device manufactured by Diagam S.A.. This product is indexed under FDA Product Code / Category Classification W01021104 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ASLTX-L00/AU
Product Code / EMDN: W01021104
Device Name: Antistreptolysin O
Database Sync Date: 2026-08-09 16:29:04

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 Antistreptolysin O?

The registered manufacturer of record for Antistreptolysin O is Diagam S.A..

What is the Primary UDI-DI identifier for Antistreptolysin O?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05415168013666.

What classification code is assigned to this device?

This device is registered under product classification code W01021104.

Similar Classification Devices (W01021104)

Other Devices by Diagam S.A.

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