GUDIDData
eudamed_udi Primary ID: 06971674869313

α1-microglobulin (α1-MG) Test Kit (Latex Enhanced Immunoturbidimetric) (UDI 06971674869313)

Manufactured by Biobase Biodustry(Shandong) Co.,Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for α1-microglobulin (α1-MG) Test Kit (Latex Enhanced Immunoturbidimetric) - Primary ID 06971674869313

Device Regulatory Overview

The α1-microglobulin (α1-MG) Test Kit (Latex Enhanced Immunoturbidimetric) (Model/Catalog Number: R1:20mL×4 R2:5mL×4(709)) is a medical device manufactured by Biobase Biodustry(Shandong) Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W0102019004 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
R1:20mL×4 R2:5mL×4(709)
Product Code / EMDN
W0102019004
Device Name
α1-microglobulin (α1-MG) Test Kit (Latex Enhanced Immunoturbidimetric)
Database Sync Date
2026-08-09 16:59:39

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 α1-microglobulin (α1-MG) Test Kit (Latex Enhanced Immunoturbidimetric)?

The registered manufacturer of record for α1-microglobulin (α1-MG) Test Kit (Latex Enhanced Immunoturbidimetric) is Biobase Biodustry(Shandong) Co.,Ltd..

What is the Primary UDI-DI identifier for α1-microglobulin (α1-MG) Test Kit (Latex Enhanced Immunoturbidimetric)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06971674869313.

What classification code is assigned to this device?

This device is registered under product classification code W0102019004.

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