ADVIA 2120i with SAA Autosampler

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA 2120i with SAA Autosampler FDA UDI
Generic Name: Haematological cell analyser IVD FDA UDI
Device Name: ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH SINGLE ASPIRATE FDA UDI
Model / Reference: 11219530 FDA UDI
Description: ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH SINGLE ASPIRATE FDA UDI

Identifiers

Catalog Number: 11219530 FDA UDI
Primary DI / UDI-DI: 00630414019789 FDA UDI
510(k) Number: K162977 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 2120i with SAA Autosampler by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K162977 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 27059857-d8e3-4971-ab7d-8aab1a625868 36 fields · synced May 30, 2026