Identity
- Trade Name
- UF-CELLSHEATH EUDAMEDFDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- UF-CELLSHEATH EUDAMEDUF-CELLSHEATH is a sheath fluid for Sysmex Fully Automated Urine Particle Analyzers. This reagent is used in combination with other reagents to obtain a count of the target substance by means of the flow cytometry method. UF-CELLSHEATH is used as a system fluid for sample aspiration and as a washing fluid with Sysmex Fully Automated Urine Particle Digital Imaging Devices. FDA UDI
- Model / Reference
- BY-074-501 EUDAMEDBY074501 FDA UDI
- Description
- UF-CELLSHEATH is a sheath fluid for Sysmex Fully Automated Urine Particle Analyzers. This reagent is used in combination with other reagents to obtain a count of the target substance by means of the flow cytometry method. UF-CELLSHEATH is used as a system fluid for sample aspiration and as a washing fluid with Sysmex Fully Automated Urine Particle Digital Imaging Devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562433926 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987562UF-CELLSHEATHLK EUDAMED
- FDA Product Code
- GIF FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) 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 — 20 Liter FDA UDI
Uf-Cellsheath 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-CELLSHEATHLK | 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 82275c75-a6e5-467b-b2b4-9226b082eada 61 fields · synced Jun 20, 2026
- FDA UDI c1c11d5a-8c2d-4921-b300-10646b212de0 36 fields · synced May 30, 2026