Unspecified Brand (UDI 06974541565622)
Manufactured by BioTeke Corporation（Wuxi）Co., Ltd
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: ICA2114-11) is a medical device manufactured by BioTeke Corporation（Wuxi）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
- ICA2114-11
- Product Code / EMDN
- W0105099099
- Device Name
- SARS-CoV-2/Flu A/Flu B/RSV/ADV/MP Antigen Rapid Test Kit
- Database Sync Date
- 2026-08-09 16:47:58
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 Unspecified Brand?
The registered manufacturer of record for Unspecified Brand is BioTeke Corporation（Wuxi）Co., Ltd.
What is the Primary UDI-DI identifier for Unspecified Brand?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974541565622.
What classification code is assigned to this device?
This device is registered under product classification code W0105099099.
Similar Classification Devices (W0105099099)
Other Devices by BioTeke Corporation（Wuxi）Co., Ltd
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