Identity
- Trade Name
- CELLSHEATH FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex. Use as a sheath fluid for hematology analyzer. FDA UDI
- Model / Reference
- 05404811 FDA UDI
- Description
- CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex. Use as a sheath fluid for hematology analyzer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562406005 FDA UDI
- FDA Product Code
- GIF FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — 10 Liter FDA UDI
Category: Buffered sample diluent IVD
Cellsheath by Sysmex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sysmex Corp.
Sources (1)
- FDA UDI 295cd126-b456-46d6-a6d4-ba1aa5ff8dfa 36 fields · synced Jun 1, 2026