eudamed_udi Primary ID: 06971674862161

Alanine Aminotransferase (ALT) Test Kit (IFCC) (UDI 06971674862161)

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

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Alanine Aminotransferase (ALT) Test Kit (IFCC) (Model/Catalog Number: R1:20mL×4 R2:5mL×4(796)) is a medical device manufactured by Biobase Biodustry(Shandong) Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W01010103 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: R1:20mL×4 R2:5mL×4(796)
Product Code / EMDN: W01010103
Device Name: Alanine Aminotransferase (ALT) Test Kit (IFCC)
Database Sync Date: 2026-08-09 16:59:21

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 Alanine Aminotransferase (ALT) Test Kit (IFCC)?

The registered manufacturer of record for Alanine Aminotransferase (ALT) Test Kit (IFCC) is Biobase Biodustry(Shandong) Co.,Ltd..

What is the Primary UDI-DI identifier for Alanine Aminotransferase (ALT) Test Kit (IFCC)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06971674862161.

What classification code is assigned to this device?

This device is registered under product classification code W01010103.

Similar Classification Devices (W01010103)

Other Devices by Biobase Biodustry(Shandong) Co.,Ltd.

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