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Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software FDA UDI
- Generic Name
- Flow cytometry analyser IVD FDA UDI
- Device Name
- Fully Automated Urine Cell Analyzer UF-1000i UF WAM FDA UDI
- Model / Reference
- UF-1000i with UF WAM FDA UDI
- Description
- Fully Automated Urine Cell Analyzer UF-1000i UF WAM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00664369000639 FDA UDI
- 510(k) Number
- K080887 FDA UDI
- FDA Product Code
- LKM FDA UDI
- GMDN Term
- Flow cytometry analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5200 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flow cytometry analyser IVD
Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software by Sysmex America, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Flow cytometry analyser IVD.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Sysmex America, Inc.
Sources (1)
- FDA UDI 2a99a7ea-493b-4efe-8777-2aba62fc0430 35 fields · synced May 30, 2026