Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method) (UDI 06978465238136)
Manufactured by Shenzhen Dake Medical Technology Co.,Ltd
Device Regulatory Overview
The Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method) (Model/Catalog Number: 100 tests) is a medical device manufactured by Shenzhen Dake Medical Technology 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
- 100 tests
- Product Code / EMDN
- W0102039001
- Device Name
- Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)
- Database Sync Date
- 2026-08-09 17:24:26
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 Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)?
The registered manufacturer of record for Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method) is Shenzhen Dake Medical Technology Co.,Ltd.
What is the Primary UDI-DI identifier for Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06978465238136.
What classification code is assigned to this device?
This device is registered under product classification code W0102039001.
Similar Classification Devices (W0102039001)
Other Devices by Shenzhen Dake Medical Technology Co.,Ltd
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