Neuron-Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay) (UDI 06970522642689)
Manufactured by Sichuan Orienter Biotechnology Co., Ltd.
Device Regulatory Overview
The Neuron-Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay) (Model/Catalog Number: DD0801) is a medical device manufactured by Sichuan Orienter Biotechnology 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
- DD0801
- Product Code / EMDN
- W0102039007
- Device Name
- Neuron-Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay)
- Database Sync Date
- 2026-08-09 18:24:42
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) Assay Kit (Chemiluminescent Immunoassay)?
The registered manufacturer of record for Neuron-Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay) is Sichuan Orienter Biotechnology Co., Ltd..
What is the Primary UDI-DI identifier for Neuron-Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06970522642689.
What classification code is assigned to this device?
This device is registered under product classification code W0102039007.
Similar Classification Devices (W0102039007)
Other Devices by Sichuan Orienter Biotechnology Co., Ltd.
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