gudid
Primary ID: AG792864
UF-Fluorocell CR (UDI AG792864)
Manufactured by SYSMEX CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for UF-Fluorocell CR - Primary ID AG792864
Device Regulatory Overview
The UF-Fluorocell CR (Model/Catalog Number: AG792864) is a medical device manufactured by SYSMEX CORPORATION. This product is indexed under FDA Product Code / Category Classification GJH within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- AG792864
- Product Code / EMDN
- GJH
- Device Name
- UF-Fluorocell CR is used to mark white blood cells, epithelial cells and bacteria, etc. in urine or in body fluids for determination of their counts with Sysmex fully automated urine particle analyzers.UF-Fluorocell CR is intended for use only in conjunction with Sysmex diluent UF-CELLPACK CR.
- Database Sync Date
- 2026-08-09 09:45:59
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of UF-Fluorocell CR?
The registered manufacturer of record for UF-Fluorocell CR is SYSMEX CORPORATION.
What is the Primary UDI-DI identifier for UF-Fluorocell CR?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is AG792864.
What classification code is assigned to this device?
This device is registered under product classification code GJH.
Similar Classification Devices (GJH)
Other Devices by SYSMEX CORPORATION
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint