FDA.reportPublic FDA data

Dimension Vista System Flex reagent cartridge A1C KIT

Primary DI
00630414006666
Brand
Dimension Vista System Flex reagent cartridge A1C KIT
Company
Siemens Healthcare Diagnostics Inc.
Model
10720885
Catalog number
K3105B
Device description
A1C Reagent Kit
Published
2019-02-12
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
PDJHemoglobin A1c test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDJHemoglobin A1c Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173909000Dimension Hemoglobin A1c AssaySiemens Healthcare Diagnostics, Inc.2018-07-13PDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414006666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414006666006304140066666304140066660630414006666

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c) in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
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
1
Lot or batch
true
Expiration date on label
true

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00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04562185405262GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONPDJ2026-01-05
04562185405279GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONPDJ2026-01-05
04562185405286GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONPDJ2026-01-05
04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONPDJ2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01TOSOH CORPORATIONPDJ2026-01-05
0456218540493790 Sample Loader TOSOH CORPORATIONPDJ2026-01-05
04562185404944290 Sample LoaderTOSOH CORPORATIONPDJ2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONPDJ2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LATOSOH CORPORATIONPDJ2026-01-05
06935784430016BioHermes Automated Glycohemoglobin AnalyzerWuxi Biohermes Bio & Medical Technology Co.,Ltd.PDJ2022-01-04
07613336120927Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics GmbHPDJ2020-04-14
07613336157824Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics GmbHPDJ2020-04-14
07070060014555Afinion HbA1c DxAbbott Diagnostics Technologies ASPDJ2019-05-31
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00630414220505Atellica CH A1c_ESiemens Healthcare Diagnostics Inc.PDJ2019-03-14
15099590012120AU BECKMAN COULTER IRELAND INC.PDJ2019-02-13
00630414006659Dimension Clinical Chemistry System A1C KitSiemens Healthcare Diagnostics Inc.PDJ2018-12-06
07070060012889Afinion HbA1c DxAbbott Diagnostics Technologies ASPDJ2018-11-01
00628063401147HbA1c AssaySekisui Diagnostics, LLCPDJ2018-09-24
00630414002859ADVIA Chemistry Enzymatic Hemoglobin A1cSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
00630414002866ADVIA Chemistry Enzymatic Hemoglobin A1cSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
00630414002880ADVIA Chemistry Enzymatic hemoglobin A1c PretreatmentSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
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04987486015116ELUENT 80CVArkray USA, Inc.PDJ2018-02-08
14987486015090ELUENT 80AARKRAY USA, INC.PDJ2018-02-08
14987486015106ELUENT 80BARKRAY USA, INC.PDJ2018-02-08
14987486015113ELUENT 80CVARKRAY USA, INC.PDJ2018-02-08