FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge GLU

Primary DI
00842768015663
Brand
Dimension Vista® Flex® reagent cartridge GLU
Company
Siemens Healthcare Diagnostics Inc.
Model
10445162
Catalog number
K1039
Device description
Glucose Flex® reagent cartridge, 480 tests
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
CFRHEXOKINASE, GLUCOSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFRHexokinase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061655000DIMENSION VISTA FLEX REAGENT CARTRIDGESDade Behring, Inc.2006-07-10LDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015663PrimaryGS10
00630414005232Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015663008427680156638427680156630842768015663
00630414005232006304140052326304140052320630414005232

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
4
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
00380740155667ARCHITECTABBOTT IRELANDCFR2026-10-15
00380740155674ARCHITECTABBOTT IRELANDCFR2026-10-15
00380740155681AlinityABBOTT IRELANDCFR2026-10-15
00380740155698AlinityABBOTT IRELANDCFR2026-10-15
00630414654126Atellica CH GluH_3Siemens Healthcare Diagnostics Inc.CFR2026-03-18
00380740215712AlinityABBOTT LABORATORIESCFR2025-10-08
00850053916113IDG/SanzayIDG/SANZAY CorporationCFR2024-06-25
10673486001693Teco Diagnostics Glucose (Hexokinase) Reagent SetTECO DIAGNOSTICSCFR2023-11-10
10673486001709Teco Diagnostics Glucose (Hexokinase) Reagent SetTECO DIAGNOSTICSCFR2023-11-10
10673486001662Teco Diagnostics Glucose (Hexokinase) Liquid ReagentTECO DIAGNOSTICSCFR2023-11-09
10673486001686Teco Diagnostics Glucose Hexokinase (Liquid) Reagent Kit for TC-MatrixTECO DIAGNOSTICSCFR2023-11-09
07613336161791Glucose HK Gen. 3 Roche Diagnostics GmbHCFR2022-11-18
00811727016157Pointe Glucose ReagentHORIBA INSTRUMENTS INCORPORATEDCFR2021-01-30
00811727015846Pointe Glucose Hexokinase for BS480HORIBA INSTRUMENTS INCORPORATEDCFR2020-05-28
03610230007013Yumizen C1200 Glucose HKHORIBA ABX SASCFR2020-05-06
03610230007020Yumizen C1200 Glucose HKHORIBA ABX SASCFR2020-05-06
07613336121283Glucose HKRoche Diagnostics GmbHCFR2020-03-05
00380740161583ARCHITECTAbbott GmbHCFR2020-01-04
00380740161590ARCHITECTAbbott GmbHCFR2020-01-04
00817238011148Glucose UV REAGENTCLINIQA CORPORATIONCFR2018-08-23
00380740135447AlinityAbbott GmbHCFR2018-07-11
00380740135454AlinityAbbott GmbHCFR2018-07-11
00852169008140ClearChem Diagnostics Inc. GlucoseCLEARCHEM DIAGNOSTICS INC.CFR2018-04-30
00630414596488Atellica CH GluH_3Siemens Healthcare Diagnostics Inc.CFR2017-12-22
00817302023152CLC720 Chemistry Analyzer w/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONCFR2016-12-19
00817302023169CLC480 Chemistry Analyzer W/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONCFR2016-12-19
00817302022995CAROLINA LIQUID CHEMISTRIES CORP.® GLU REAGENT PRODUCT NO. DT208CAROLINA LIQUID CHEMISTRIES CORPORATIONCFR2016-10-17
00812137011985Glucose ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CFR2016-10-12
15099590010195AUBeckman Coulter, Inc.CFR2016-09-24
15099590020101AUBeckman Coulter, Inc.CFR2016-09-24