Identity
- Trade Name
- CELLPACK DFL EUDAMEDFDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- CELLPACK DFL EUDAMEDCELLPACK 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. FDA UDI
- Model / Reference
- AR-829-995 EUDAMEDFDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562432387 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987562CELLPACKDFLXJ EUDAMED
- FDA Product Code
- GIF FDA UDI
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Liter FDA UDI
Cellpack Dfl by Sysmex Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4987562CELLPACKDFLXJ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (2)
- EUDAMED f44d35f0-9b53-4014-ac68-4c4960e18118 61 fields · synced Jun 18, 2026
- FDA UDI 70265e95-d8f1-484d-968a-0e20b03e39f6 36 fields · synced May 29, 2026