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ADVIA® 360 Lyse 3P Diff
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 11170848Model IVDR_67_TTN_DUB-C_A_REAG_Lyse 3P Diff
Identity
- Trade Name
- ADVIA® 360 Lyse 3P Diff EUDAMEDFDA UDI
- Generic Name
- Blood cell lysis reagent IVD FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_A_REAG_Lyse 3P Diff EUDAMEDADVIA® 360 Lyse 3P Diff FDA UDI
- Model / Reference
- 11170848 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_A_REAG_Lyse 3P Diff EUDAMED
- Description
- ADVIA® 360 Lyse 3P Diff FDA UDI
Identifiers
- Catalog Number
- D2011HK FDA UDI
- Primary DI / UDI-DI
- 00630414601281 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901745W3 EUDAMED
- 510(k) Number
- K112755 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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: Blood cell lysis reagent IVD
ADVIA® 360 Lyse 3P Diff 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
- Diatro•Lyse-5P — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag · Class I
- 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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 9527d9d9-a100-4fc2-a12e-05032686a9cf 37 fields · synced Jul 21, 2026
- EUDAMED 8bacff09-167a-48dc-904f-f0880dbd719a 61 fields · synced Jul 21, 2026