Identity
- Trade Name
- ADVIA® 560 5P Diff 1L FDA UDI
- Generic Name
- White blood cell count IVD, kit, cell count FDA UDI
- Device Name
- ADVIA® 560 5P Diff 1L FDA UDI
- Model / Reference
- 11170847 FDA UDI
- Description
- ADVIA® 560 5P Diff 1L FDA UDI
Identifiers
- Catalog Number
- D3021 FDA UDI
- Primary DI / UDI-DI
- 00630414601885 FDA UDI
- 510(k) Number
- K111534 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- White blood cell count IVD, kit, cell count FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: White blood cell count IVD, kit, cell count
ADVIA® 560 5P Diff 1L by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111534 also covers:
- ADVIA® 360 Hematology System — Siemens Healthcare Diagnostics
- ADVIA® 360.560 Hypoclean 1L — Siemens Healthcare Diagnostics
- ADVIA® 360/560 Dil (20L) — Siemens Healthcare Diagnostics
- ADVIA® 360/560 Hypoclean 100 mL — Siemens Healthcare Diagnostics
- ADVIA® 560 Hematology System Auto-loader — Siemens Healthcare Diagnostics
- ADVIA® 560 Lyse — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI a154cffc-16f6-4b9d-8014-2d81fcdf643d 37 fields · synced Jun 1, 2026