Identity
- Trade Name
- ADVIA® 360/560 Hypoclean 100 mL FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- ADVIA® 360/560 Hypoclean 100ml FDA UDI
- Model / Reference
- 11170851 FDA UDI
- Description
- ADVIA® 360/560 Hypoclean 100ml FDA UDI
Identifiers
- Catalog Number
- D8011 FDA UDI
- Primary DI / UDI-DI
- 00630414601311 FDA UDI
- 510(k) Number
- K111534 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system 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: Wash/cleaning solution IVD, automated/semi-automated system
ADVIA® 360/560 Hypoclean 100 mL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wash/cleaning solution IVD, automated/semi-automated system.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class I
- DAB Away — BIOCARE MEDICAL, LLC · Class I
- ACE — Alfa Wassermann, Inc.
- Capillary Adapter Cleaning Kit — Medica Corp. · Class II
- Rinse Solution II S4987 REF 944-155 600mL — Radiometer Medical ApS · Class II
- intelliPrep Solution — BIOCARE MEDICAL, LLC · Class I
- Grifols Wash Solution B — DIAGNOSTIC GRIFOLS SA · Class I
- CLC FAST DETERGENT 1 ALKALINE WASHING SOLUTION 100263 — Carolina Liquid Chemistries Corp. · 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® 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI a43cc7ad-9728-4c03-ad8a-7c525f9dc36b 37 fields · synced May 31, 2026