Identity
- Trade Name
- UF-CELLPACK CR FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- UF-CELLPACK CR EUDAMEDUF-CELLPACK CR is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended for use only in conjunction with UF-Fluorocell CR. UF-CELLPACK CR is used to mark formed elements in urine (or in body fluid (cerebrospinal fluid, etc.)) for determination of nucleated specimens (white blood cells, epithelial cells and bacteria, etc.). FDA UDI
- Model / Reference
- CB-505-392 EUDAMEDCB505392 FDA UDI
- Description
- UF-CELLPACK CR is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended for use only in conjunction with UF-Fluorocell CR. UF-CELLPACK CR is used to mark formed elements in urine (or in body fluid (cerebrospinal fluid, etc.)) for determination of nucleated specimens (white blood cells, epithelial cells and bacteria, etc.). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562433940 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987562UF-CELLPACKCRH4 EUDAMED
- FDA Product Code
- GIF FDA UDI
- EMDN Code
- W01010999 MULTIPLE PARAMETERS URINE TESTING - OTHER 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 — 2.1 Liter FDA UDI
Uf-Cellpack Cr 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 | 4987562UF-CELLPACKCRH4 | 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 f302cddc-0bad-4ba3-a862-77f3ec50308a 61 fields · synced Jun 19, 2026
- FDA UDI a2a15467-e4c3-4a78-be60-b511e2e6a070 36 fields · synced May 30, 2026