ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold) (UDI 06974521001935)
Manufactured by Shenzhen Superbio Technology Co.,Ltd.
Device Regulatory Overview
The ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold) (Model/Catalog Number: SUPG017025-1) is a medical device manufactured by Shenzhen Superbio Technology Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W0105099099 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SUPG017025-1
- Product Code / EMDN
- W0105099099
- Device Name
- ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold)
- Database Sync Date
- 2026-08-09 16:30:34
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold)?
The registered manufacturer of record for ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold) is Shenzhen Superbio Technology Co.,Ltd..
What is the Primary UDI-DI identifier for ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974521001935.
What classification code is assigned to this device?
This device is registered under product classification code W0105099099.
Similar Classification Devices (W0105099099)
Other Devices by Shenzhen Superbio Technology Co.,Ltd.
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