Urea/BUN – (Modified Urease - Berthlot Method) (UDI 62230041038728)
Manufactured by Egyptian Company For Biotechnology-Spectrum Diagnostics
Device Regulatory Overview
The Urea/BUN – (Modified Urease - Berthlot Method) (Model/Catalog Number: 318 003) is a medical device manufactured by Egyptian Company For Biotechnology-Spectrum Diagnostics. This product is indexed under FDA Product Code / Category Classification W01010204 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 318 003
- Product Code / EMDN
- W01010204
- Device Name
- Urea/BUN – (Modified Urease - Berthlot Method)
- Database Sync Date
- 2026-08-09 16:28:47
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 – (Modified Urease - Berthlot Method)?
The registered manufacturer of record for Urea/BUN – (Modified Urease - Berthlot Method) is Egyptian Company For Biotechnology-Spectrum Diagnostics.
What is the Primary UDI-DI identifier for Urea/BUN – (Modified Urease - Berthlot Method)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 62230041038728.
What classification code is assigned to this device?
This device is registered under product classification code W01010204.
Similar Classification Devices (W01010204)
Other Devices by Egyptian Company For Biotechnology-Spectrum Diagnostics
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