AFP Assay Kit (ECLIA) (UDI D-SEK001D8)
Manufactured by Jiangsu Sunlant Bioengineering Co., Ltd.
Device Regulatory Overview
The AFP Assay Kit (ECLIA) (Model/Catalog Number: SE-K001) is a medical device manufactured by Jiangsu Sunlant Bioengineering Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102039001 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SE-K001
- Product Code / EMDN
- W0102039001
- Device Name
- AFP Assay Kit (ECLIA)
- Database Sync Date
- 2026-08-09 17:11:29
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 AFP Assay Kit (ECLIA)?
The registered manufacturer of record for AFP Assay Kit (ECLIA) is Jiangsu Sunlant Bioengineering Co., Ltd..
What is the Primary UDI-DI identifier for AFP Assay Kit (ECLIA)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-SEK001D8.
What classification code is assigned to this device?
This device is registered under product classification code W0102039001.
Similar Classification Devices (W0102039001)
Other Devices by Jiangsu Sunlant Bioengineering Co., Ltd.
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