ADVIA® 560 Lyse
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA® 560 Lyse EUDAMEDFDA UDI
- Generic Name
- Blood cell lysis reagent IVD FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_A_REAG_Lyse EUDAMEDADVIA® 560 Lyse FDA UDI
- Model / Reference
- 11170846 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_A_REAG_Lyse EUDAMED
- Description
- ADVIA® 560 Lyse FDA UDI
Identifiers
- Catalog Number
- D3015 FDA UDI
- Primary DI / UDI-DI
- 00630414601878 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901744VZ EUDAMED
- 510(k) Number
- K111534 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
- GMDN Term
- Blood cell lysis reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Blood cell lysis reagent IVD
ADVIA® 560 Lyse by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood cell lysis reagent IVD.
- Stromatolyser-NR — Sysmex Corp. · Class I
- ZAPR™ — INCELL CORPORATION, LLC · Class I
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- STROMATOLYSER-IM — Sysmex Corp. · Class I
- STROMATOLYSER-4DS — Sysmex Corp. · Class I
- STROMATOLYSER-FB — Sysmex Corp. · Class I
- STROMATOLYSER-NR (L) — Sysmex Corp. · Class I
- MINILYSEBIO (1L) — Horiba Abx · Class I
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 5P Diff 1L — Siemens Healthcare Diagnostics
- ADVIA® 560 Hematology System Auto-loader — Siemens Healthcare Diagnostics
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 2650b777-d5d2-43dc-8eec-82d985025c6e 37 fields · synced Aug 2, 2026
- EUDAMED 1f8b4c94-390b-4c10-891d-5cc273f3ec94 61 fields · synced Aug 2, 2026