Entamoeba histolytica IgG ELISA (UDI 07640158219553)
Manufactured by Bordier Affinity Products SA
Device Regulatory Overview
The Entamoeba histolytica IgG ELISA (Model/Catalog Number: 9550) is a medical device manufactured by Bordier Affinity Products SA. This product is indexed under FDA Product Code / Category Classification W0105050201 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 9550
- Product Code / EMDN
- W0105050201
- Device Name
- Entamoeba histolytica IgG ELISA
- Database Sync Date
- 2026-08-09 18:07:38
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 Entamoeba histolytica IgG ELISA?
The registered manufacturer of record for Entamoeba histolytica IgG ELISA is Bordier Affinity Products SA.
What is the Primary UDI-DI identifier for Entamoeba histolytica IgG ELISA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07640158219553.
What classification code is assigned to this device?
This device is registered under product classification code W0105050201.
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