Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） (UDI 06974969981929)
Manufactured by Biobase Diagnostic Technology (Shandong) Co., Ltd.
Device Regulatory Overview
The Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） (Model/Catalog Number: 100 Tests/kit（DR1095-2）) is a medical device manufactured by Biobase Diagnostic Technology (Shandong) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102039007 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 100 Tests/kit（DR1095-2）
- Product Code / EMDN
- W0102039007
- Device Name
- Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）
- Database Sync Date
- 2026-08-09 17:20:22
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 Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）?
The registered manufacturer of record for Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） is Biobase Diagnostic Technology (Shandong) Co., Ltd..
What is the Primary UDI-DI identifier for Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974969981929.
What classification code is assigned to this device?
This device is registered under product classification code W0102039007.
Similar Classification Devices (W0102039007)
Other Devices by Biobase Diagnostic Technology (Shandong) Co., Ltd.
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