Identity
- Trade Name
- ADVIA® 360 Hematology System FDA UDI
- Generic Name
- Haematological cell analyser IVD FDA UDI
- Device Name
- ADVIA® 360 Hematology System FDA UDI
- Model / Reference
- 11170841 FDA UDI
- Description
- ADVIA® 360 Hematology System FDA UDI
Identifiers
- Catalog Number
- A3CT-SIE FDA UDI
- Primary DI / UDI-DI
- 00630414601250 FDA UDI
- 510(k) Number
- K111534 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- Haematological cell analyser IVD 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haematological cell analyser IVD
ADVIA® 360 Hematology System by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haematological cell analyser IVD.
- ABX PENTRA DX 120 — Horiba Abx · Class II
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- Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays — Advanced Instruments, LLC · Class II
- Medonic M-series — Boule Medical AB · Class II
- Automated Hematology Analyzer XS series XS-1000i — Sysmex Corp. · Class II
- 0.5ml tube adpater — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K111534 also covers:
- 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 5P Diff 1L — 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 3f38c74c-eafb-43e5-ba4a-a89dba7fcacb 37 fields · synced Jun 1, 2026