GUDIDData
eudamed_udi Primary ID: D-SC20102W-1TZC

Malaria Pf (HRP2) Ag Rapid Test Kit (UDI D-SC20102W-1TZC)

Manufactured by Jiangsu Bioperfectus Technologies Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Malaria Pf (HRP2) Ag Rapid Test Kit - Primary ID D-SC20102W-1TZC

Device Regulatory Overview

The Malaria Pf (HRP2) Ag Rapid Test Kit (Model/Catalog Number: SC20102W-1T) is a medical device manufactured by Jiangsu Bioperfectus Technologies Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0105090401 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
SC20102W-1T
Product Code / EMDN
W0105090401
Device Name
Malaria Pf (HRP2) Ag Rapid Test Kit
Database Sync Date
2026-08-09 16:58:52

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 Malaria Pf (HRP2) Ag Rapid Test Kit?

The registered manufacturer of record for Malaria Pf (HRP2) Ag Rapid Test Kit is Jiangsu Bioperfectus Technologies Co., Ltd..

What is the Primary UDI-DI identifier for Malaria Pf (HRP2) Ag Rapid Test Kit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-SC20102W-1TZC.

What classification code is assigned to this device?

This device is registered under product classification code W0105090401.

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