Unspecified Brand (UDI 06974541565486)
Manufactured by BioTeke Corporation（Wuxi）Co., Ltd
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: ICA2230) is a medical device manufactured by BioTeke Corporation（Wuxi）Co., Ltd. This product is indexed under FDA Product Code / Category Classification W0102160304 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ICA2230
- Product Code / EMDN
- W0102160304
- Device Name
- Luteinising Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)
- Database Sync Date
- 2026-08-09 17:34:26
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 06974541565486.
What classification code is assigned to this device?
This device is registered under product classification code W0102160304.
Similar Classification Devices (W0102160304)
Other Devices by BioTeke Corporation（Wuxi）Co., Ltd
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