COVID-19 Antigen Rapid Test Cassette (Nasal Swab) (UDI D-ICOVu00A4)
Manufactured by Hangzhou Clongene Biotech Co., Ltd.
Device Regulatory Overview
The COVID-19 Antigen Rapid Test Cassette (Nasal Swab) (Model/Catalog Number: ICOVu002) is a medical device manufactured by Hangzhou Clongene 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
- ICOVu002
- Product Code / EMDN
- W0105099099
- Device Name
- COVID-19 Antigen Rapid Test Cassette (Nasal Swab)
- Database Sync Date
- 2026-08-09 17:27:17
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 Antigen Rapid Test Cassette (Nasal Swab)?
The registered manufacturer of record for COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is Hangzhou Clongene Biotech Co., Ltd..
What is the Primary UDI-DI identifier for COVID-19 Antigen Rapid Test Cassette (Nasal Swab)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-ICOVu00A4.
What classification code is assigned to this device?
This device is registered under product classification code W0105099099.
Similar Classification Devices (W0105099099)
Other Devices by Hangzhou Clongene Biotech Co., Ltd.
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