Unspecified Brand (UDI +ENTIENTG0140DS0_)
Manufactured by Gold Standard Diagnostics Frankfurt GmbH
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: ENTG0140DS) is a medical device manufactured by Gold Standard Diagnostics Frankfurt GmbH. This product is indexed under FDA Product Code / Category Classification W0105050201 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ENTG0140DS
- Product Code / EMDN
- W0105050201
- Device Name
- NovaLisa® Entamoeba histolytica IgG
- Database Sync Date
- 2026-08-09 17:40:49
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 Gold Standard Diagnostics Frankfurt GmbH.
What is the Primary UDI-DI identifier for Unspecified Brand?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is +ENTIENTG0140DS0_.
What classification code is assigned to this device?
This device is registered under product classification code W0105050201.
Similar Classification Devices (W0105050201)
Other Devices by Gold Standard Diagnostics Frankfurt GmbH
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