gudid
Primary ID: BT-965-910
CELLPACK DFL (UDI BT-965-910)
Manufactured by SYSMEX CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CELLPACK DFL - Primary ID BT-965-910
Device Regulatory Overview
The CELLPACK DFL (Model/Catalog Number: BT-965-910) is a medical device manufactured by SYSMEX CORPORATION. This product is indexed under FDA Product Code / Category Classification GIF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- BT-965-910
- Product Code / EMDN
- GIF
- Device Name
- CELLPACK DFL is a reagent used in combination with Fluorocell RET for the analysis of reticulocytes or with Fluorocell PLT for the analysis of platelets by flow cytometry method using a semiconductor laser. This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex.
- Database Sync Date
- 2026-08-09 09:45:59
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 CELLPACK DFL?
The registered manufacturer of record for CELLPACK DFL is SYSMEX CORPORATION.
What is the Primary UDI-DI identifier for CELLPACK DFL?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BT-965-910.
What classification code is assigned to this device?
This device is registered under product classification code GIF.
Similar Classification Devices (GIF)
Other Devices by SYSMEX CORPORATION
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