GENCHEMElectrode, Ion Specific, Urea Nitrogen (BUN) reagent (UDI GEN-BUN LX)
Manufactured by GENCHEM INC
Device Regulatory Overview
The GENCHEMElectrode, Ion Specific, Urea Nitrogen (BUN) reagent (Model/Catalog Number: GEN-BUN LX) is a medical device manufactured by GENCHEM INC. This product is indexed under FDA Product Code / Category Classification CDS within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- GEN-BUN LX
- Product Code / EMDN
- CDS
- Device Name
- 10/17/2022
- Database Sync Date
- 2026-08-09 09:49:36
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 GENCHEMElectrode, Ion Specific, Urea Nitrogen (BUN) reagent?
The registered manufacturer of record for GENCHEMElectrode, Ion Specific, Urea Nitrogen (BUN) reagent is GENCHEM INC.
What is the Primary UDI-DI identifier for GENCHEMElectrode, Ion Specific, Urea Nitrogen (BUN) reagent?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GEN-BUN LX.
What classification code is assigned to this device?
This device is registered under product classification code CDS.
Similar Classification Devices (CDS)
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