FDA.reportPublic FDA data

Dimension® Sample Diluent

Primary DI
00842768000119
Brand
Dimension® Sample Diluent
Company
Siemens Healthcare Diagnostics Inc.
Model
10444875
Catalog number
791092901
Device description
Sample Diluent, 2 bottles, 50 mL per bottle
Published
2020-09-24
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
JMGRadioimmunoassay (two-site solid phase), ferritin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMGRadioimmunoassay (Two-Site Solid Phase), FerritinImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768000119PrimaryGS10
00630414016948Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768000119008427680001198427680001190842768000119
00630414016948006304140169486304140169480630414016948

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
2
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590772840Access FerritinBeckman Coulter, Inc.JMG2024-04-05
00842768013768Dimension® Reagent Probe CleanerSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768013775Dimension® Sample Probe CleanerSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768013782Dimension® IMT Probe CleanerSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768014277Dimension® Chemistry WashSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00816870020303Ferritin AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JMG2019-02-11
00816870020310Ferritin AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JMG2019-02-11
00816870021980Ferritin AccuLite CLIA Test System - 96 WellsMONOBIND, INC.JMG2019-02-11
00816870021997Ferritin AccuLite CLIA Test System - 192 WellsMONOBIND, INC.JMG2019-02-11
00842768013928Dimension® Reaction VesselsSiemens Healthcare Diagnostics Inc.JMG2018-09-24
04015630939688Elecsys FerritinRoche Diagnostics GmbHJMG2017-04-21
00842768013867Dimension® Flex® reagent cartridge FERRSiemens Healthcare Diagnostics Inc.JMG2016-09-24
00630414953748IMMULITE®/IMMULITE® 1000 Systems FER Ferritin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
00630414961460IMMULITE® 2000 Systems FER FerritinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
00630414961477IMMULITE® 2000 Systems FER FerritinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
00630414963976IMMULITE®/IMMULITE® 1000 Systems FER FerritinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
04015630920242Elecsys Ferritin CalSetRoche Diagnostics GmbHJMG2016-09-20
04015630938940Elecsys FerritinRoche Diagnostics GmbHJMG2016-09-20
04015630938957Elecsys FerritinRoche Diagnostics GmbHJMG2016-09-20
15099590575045Access Ferritin CalibratorsBeckman Coulter, Inc.JMG2016-09-09
15099590575052Access FerritinBeckman Coulter, Inc.JMG2016-09-09