Urea/BUN - LS (Modified Urease-Berthlot Method) (UDI G458321003AJ)
Manufactured by Spectrum for Diagnostic Industries (Joint Stock Company)
Device Regulatory Overview
The Urea/BUN - LS (Modified Urease-Berthlot Method) (Model/Catalog Number: 321 003) is a medical device manufactured by Spectrum for Diagnostic Industries (Joint Stock Company). This product is indexed under FDA Product Code / Category Classification W01010204 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 321 003
- Product Code / EMDN
- W01010204
- Device Name
- Urea/BUN - LS (Modified Urease-Berthlot Method)
- Database Sync Date
- 2026-08-09 16:45:43
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 Urea/BUN - LS (Modified Urease-Berthlot Method)?
The registered manufacturer of record for Urea/BUN - LS (Modified Urease-Berthlot Method) is Spectrum for Diagnostic Industries (Joint Stock Company).
What is the Primary UDI-DI identifier for Urea/BUN - LS (Modified Urease-Berthlot Method)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is G458321003AJ.
What classification code is assigned to this device?
This device is registered under product classification code W01010204.
Similar Classification Devices (W01010204)
Other Devices by Spectrum for Diagnostic Industries (Joint Stock Company)
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