gudid
Primary ID: GEN-TBILI R1
GENCHEM Total Bilirubin Reagent (UDI GEN-TBILI R1)
Manufactured by GENCHEM INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GENCHEM Total Bilirubin Reagent - Primary ID GEN-TBILI R1
Device Regulatory Overview
The GENCHEM Total Bilirubin Reagent (Model/Catalog Number: GEN-TBILI R1) is a medical device manufactured by GENCHEM INC. This product is indexed under FDA Product Code / Category Classification CIG within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- GEN-TBILI R1
- Product Code / EMDN
- CIG
- 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 GENCHEM Total Bilirubin Reagent?
The registered manufacturer of record for GENCHEM Total Bilirubin Reagent is GENCHEM INC.
What is the Primary UDI-DI identifier for GENCHEM Total Bilirubin Reagent?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GEN-TBILI R1.
What classification code is assigned to this device?
This device is registered under product classification code CIG.
Similar Classification Devices (CIG)
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