Smart Rapid COVID-19 & Flu A/B Ag Test Device (UDI D-GCFC-T503aUH)
Manufactured by Zhejiang Orient Gene Biotech Co., Ltd
Device Regulatory Overview
The Smart Rapid COVID-19 & Flu A/B Ag Test Device (Model/Catalog Number: GCFC-T503a) is a medical device manufactured by Zhejiang Orient Gene Biotech Co., Ltd. This product is indexed under FDA Product Code / Category Classification W0105090601 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- GCFC-T503a
- Product Code / EMDN
- W0105090601
- Device Name
- Smart Rapid COVID-19 & Flu A/B Ag Test Device
- Database Sync Date
- 2026-08-09 16:28:53
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 Smart Rapid COVID-19 & Flu A/B Ag Test Device?
The registered manufacturer of record for Smart Rapid COVID-19 & Flu A/B Ag Test Device is Zhejiang Orient Gene Biotech Co., Ltd.
What is the Primary UDI-DI identifier for Smart Rapid COVID-19 & Flu A/B Ag Test Device?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-GCFC-T503aUH.
What classification code is assigned to this device?
This device is registered under product classification code W0105090601.
Similar Classification Devices (W0105090601)
Other Devices by Zhejiang Orient Gene Biotech Co., Ltd
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