FDA.reportPublic FDA data

ADVIA 2120i wthout Autosampler

Primary DI
00630414019796
Brand
ADVIA 2120i wthout Autosampler
Company
Siemens Healthcare Diagnostics Inc.
Model
11219531
Catalog number
11219531
Device description
ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITHOUT AUTOSAMPLER
Published
2018-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKZCounter, differential cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162977000ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics2017-08-11GKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414019796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414019796006304140197966304140197960630414019796

GMDN Terms#

Term, Definition table
TermDefinition
Haematological cell analyser IVD, automatedAn electrically-powered laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Serial number
true

Other Devices From This Company#

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00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
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00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
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00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
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00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

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