ADVIA® 560 Hematology System

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA® 560 Hematology System FDA UDI
Generic Name: Haematological cell analyser IVD FDA UDI
Device Name: ADVIA® 560 Hematology System FDA UDI
Model / Reference: 11170842 FDA UDI
Description: ADVIA® 560 Hematology System FDA UDI

Identifiers

Catalog Number: A5-SIE FDA UDI
Primary DI / UDI-DI: 00630414601816 FDA UDI
510(k) Number: K112755 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Haematological cell analyser IVD

ADVIA® 560 Hematology System by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

K112755 also covers:

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 abd86c5e-cbf5-4a22-a571-0583a9eaddd0 37 fields · synced Jun 7, 2026