COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) (UDI 06950996002288)
Manufactured by Zhejiang Orient Gene Biotech Co., Ltd
Device Regulatory Overview
The COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) (Model/Catalog Number: GCFC-T502a-H1) is a medical device manufactured by Zhejiang Orient Gene Biotech 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
- GCFC-T502a-H1
- Product Code / EMDN
- W0105099099
- Device Name
- COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
- Database Sync Date
- 2026-08-09 16:30:15
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 COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)?
The registered manufacturer of record for COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is Zhejiang Orient Gene Biotech Co., Ltd.
What is the Primary UDI-DI identifier for COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06950996002288.
What classification code is assigned to this device?
This device is registered under product classification code W0105099099.
Similar Classification Devices (W0105099099)
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