Identity
- Trade Name
- UF II PACK-SED FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- UFII PACK -SED is a diluent for Sysmex fully automated urine particle analyzers, and is intended for use only in conjunction with UFII SEARCH -SED. UFII PACK -SED dilutes the aspirated sample for the determination of the parameters, Red Blood Cell (RBC), White Blood Cell (WBC), Epithelial Cells (EC) and Casts (CAST) count, by fluorescence flow cytometry method. FDA UDI
- Model / Reference
- 06401615 FDA UDI
- Description
- UFII PACK -SED is a diluent for Sysmex fully automated urine particle analyzers, and is intended for use only in conjunction with UFII SEARCH -SED. UFII PACK -SED dilutes the aspirated sample for the determination of the parameters, Red Blood Cell (RBC), White Blood Cell (WBC), Epithelial Cells (EC) and Casts (CAST) count, by fluorescence flow cytometry method. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562408382 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
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Premarket Exempt
Yes
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
Yes
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Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2.1 Liter FDA UDI
Category: Buffered sample diluent IVD
Uf Ii Pack-Sed 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 c9d27de1-a7be-4363-b548-5e5d53e4338b 36 fields · synced May 30, 2026