GUDIDData
eudamed_udi Primary ID: 06942359511643

HS-cTnT CLIA Microparticles (UDI 06942359511643)

Manufactured by Autobio Diagnostics Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HS-cTnT CLIA Microparticles - Primary ID 06942359511643

Device Regulatory Overview

The HS-cTnT CLIA Microparticles (Model/Catalog Number: CMH0610) is a medical device manufactured by Autobio Diagnostics Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W01021306 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
CMH0610
Product Code / EMDN
W01021306
Device Name
AutoLumo analyzer
Database Sync Date
2026-08-09 16:28:53

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 HS-cTnT CLIA Microparticles?

The registered manufacturer of record for HS-cTnT CLIA Microparticles is Autobio Diagnostics Co., Ltd..

What is the Primary UDI-DI identifier for HS-cTnT CLIA Microparticles?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06942359511643.

What classification code is assigned to this device?

This device is registered under product classification code W01021306.

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