gudid
Primary ID: 09127127190
Elecsys HBsAg Confirmatory Test (UDI 09127127190)
Manufactured by Roche Diagnostics GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Elecsys HBsAg Confirmatory Test - Primary ID 09127127190
Device Regulatory Overview
The Elecsys HBsAg Confirmatory Test (Model/Catalog Number: 09127127190) is a medical device manufactured by Roche Diagnostics GmbH. This product is indexed under FDA Product Code / Category Classification LOM within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 09127127190
- Product Code / EMDN
- LOM
- Device Name
- HBsAg Confirmatory Test Elecsys cobas e V2
- Database Sync Date
- 2026-08-09 09:44:46
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 Elecsys HBsAg Confirmatory Test?
The registered manufacturer of record for Elecsys HBsAg Confirmatory Test is Roche Diagnostics GmbH.
What is the Primary UDI-DI identifier for Elecsys HBsAg Confirmatory Test?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 09127127190.
What classification code is assigned to this device?
This device is registered under product classification code LOM.
Similar Classification Devices (LOM)
Other Devices by Roche Diagnostics GmbH
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