gudid
Primary ID: BK-443350D
BUN Reagent (UDI BK-443350D)
Manufactured by Diamond Diagnostics Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BUN Reagent - Primary ID BK-443350D
Device Regulatory Overview
The BUN Reagent (Model/Catalog Number: BK-443350D) is a medical device manufactured by Diamond Diagnostics Inc.. This product is indexed under FDA Product Code / Category Classification CDS within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- BK-443350D
- Product Code / EMDN
- CDS
- Device Name
- For the quantitative determination of urea nitrogen in serum or plasma.
- Database Sync Date
- 2026-08-09 09:22:15
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 BUN Reagent?
The registered manufacturer of record for BUN Reagent is Diamond Diagnostics Inc..
What is the Primary UDI-DI identifier for BUN Reagent?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BK-443350D.
What classification code is assigned to this device?
This device is registered under product classification code CDS.
Similar Classification Devices (CDS)
Other Devices by Diamond Diagnostics Inc.
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