Unspecified Brand (UDI 06937287300643)
Manufactured by Shenzhen AmTech Bioengineering Ltd., Inc.
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: 100 tests/kit) is a medical device manufactured by Shenzhen AmTech Bioengineering Ltd., Inc.. 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/kit
- Product Code / EMDN
- W0102039001
- Device Name
- Alpha-Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay)
- Database Sync Date
- 2026-08-09 16:52:02
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 Shenzhen AmTech Bioengineering Ltd., Inc..
What is the Primary UDI-DI identifier for Unspecified Brand?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06937287300643.
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 AmTech Bioengineering Ltd., Inc.
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