eudamed_udi Primary ID: D-SC10101W-50TUG

Influenza A&B Rapid Test Kit (UDI D-SC10101W-50TUG)

Manufactured by Jiangsu Bioperfectus Technologies Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Influenza A&B Rapid Test Kit (Model/Catalog Number: SC10101W-50T) is a medical device manufactured by Jiangsu Bioperfectus Technologies Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0105099004 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: SC10101W-50T
Product Code / EMDN: W0105099004
Device Name: Influenza A&B Rapid Test Kit
Database Sync Date: 2026-08-09 17:04:46

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 Influenza A&B Rapid Test Kit?

The registered manufacturer of record for Influenza A&B Rapid Test Kit is Jiangsu Bioperfectus Technologies Co., Ltd..

What is the Primary UDI-DI identifier for Influenza A&B Rapid Test Kit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-SC10101W-50TUG.

What classification code is assigned to this device?

This device is registered under product classification code W0105099004.

Similar Classification Devices (W0105099004)

Other Devices by Jiangsu Bioperfectus Technologies Co., Ltd.

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