GUDIDData
eudamed_udi Primary ID: 06947145583347

Biossays α1-Microglobulin (Latex Immunoturbidimetric) (UDI 06947145583347)

Manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Biossays α1-Microglobulin (Latex Immunoturbidimetric) - Primary ID 06947145583347

Device Regulatory Overview

The Biossays α1-Microglobulin (Latex Immunoturbidimetric) (Model/Catalog Number: 130553005S) is a medical device manufactured by Shenzhen New Industries Biomedical Engineering 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
130553005S
Product Code / EMDN
W0102019004
Device Name
α1-Microglobulin (Latex Immunoturbidimetric)
Database Sync Date
2026-08-09 18:05:31

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 Biossays α1-Microglobulin (Latex Immunoturbidimetric)?

The registered manufacturer of record for Biossays α1-Microglobulin (Latex Immunoturbidimetric) is Shenzhen New Industries Biomedical Engineering Co., Ltd..

What is the Primary UDI-DI identifier for Biossays α1-Microglobulin (Latex Immunoturbidimetric)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06947145583347.

What classification code is assigned to this device?

This device is registered under product classification code W0102019004.

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