FDA.reportPublic FDA data

ADVIA 120/2120/2120i® OPTIpoint

Primary DI
00630414224329
Brand
ADVIA 120/2120/2120i® OPTIpoint
Company
Siemens Healthcare Diagnostics Inc.
Model
10312283
Catalog number
T03-3682-54
Device description
ADVIA®120/2120/2120i OPTIpoint™
Published
2016-09-24
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
GKLCOUNTER, CELL, AUTOMATED (PARTICLE COUNTER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKLCounter, Cell, Automated (Particle Counter)Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971998000ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEMBayer Corp.1997-08-29GKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414224329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414224329006304142243296304142243290630414224329

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Protect from freezing
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414222882ADVIA® 120/2120/2120i CBC TIMEpacSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222899ADVIA 120/2120/2120i® DIFF TIMEpacSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222905ADVIA 120/2120/2120i® autoRETICSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222912ADVIA 120/2120/2120i® AUTOreticSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222929ADVIA 120/2120/2120i® Sheath/RinseSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222943ADVIA 120/2120/2120i® DefoamerSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222950ADVIA 120/2120/2120i® CN-FREE CBC TIMEPACSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414223032ADVIA 120/2120/2120i® Sheath/RinseSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414224305ADVIA 120/2120/2120i® OPTIpointSiemens Healthcare Diagnostics Inc.GKL2016-09-24
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