Identity
- Trade Name
- UF II PACK-BAC FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- UFII PACK -BAC is a diluent to analyze bacteria in urine for determination of the bacterial count with the Sysmex Fully Automated Urine Particle Analyzers UF-1000i and UF-500i. FDA UDI
- Model / Reference
- 06401712 FDA UDI
- Description
- UFII PACK -BAC is a diluent to analyze bacteria in urine for determination of the bacterial count with the Sysmex Fully Automated Urine Particle Analyzers UF-1000i and UF-500i. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562408399 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 — 2.1 Liter FDA UDI
Category: Buffered sample diluent IVD
Uf Ii Pack-Bac 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 64a5c203-4d3f-42df-abb8-c4d087e3c7c3 36 fields · synced May 29, 2026