FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge T4

Primary DI
00842768015434
Brand
Dimension Vista® Flex® reagent cartridge T4
Company
Siemens Healthcare Diagnostics Inc.
Model
10445101
Catalog number
K6065
Device description
Thyroxine Flex® reagent cartridge, 160 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
KLIEnzyme immunoassay, non-radiolabeled, total thyroxine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLIEnzyme Immunoassay, Non-Radiolabeled, Total ThyroxineClinical 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
00842768015434PrimaryGS10
00630414004754Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015434008427680154348427680154340842768015434
00630414004754006304140047546304140047540630414004754

GMDN Terms#

Term, Definition table
TermDefinition
Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of total thyroxine (TT4) in a clinical specimen, using an enzyme immunoassay (EIA) 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
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27
00630414597508Atellica CH hsCRP Calibrator11099412110994122017-12-22
00630414597515Atellica CH CRP_2 Calibrator11099430110994302017-12-22
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414611297Atellica CH RCRP Cal11537245115372452024-02-02
00842768037726Dimension EXL LOCI Troponin I High Sensitive10471068104710682019-10-16
00630414596099Atellica CH Thc11097503110975032017-12-27
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414653259Atellica CH Crea311537567115375672026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590754488Access Total T4 IIBeckman Coulter, Inc.KLI2025-09-19
00816870023489T4 High Sensitivity AccuBind ELISA Test System - 96 wellsMONOBIND, INC.KLI2024-09-13
00816870024851T4 High Sensitivity AccuBind ELISA Test System - 192 wellsMONOBIND, INC.KLI2024-09-13
00850049545983QMedix™Diagnostic Automation, Inc.KLI2024-02-02
04048474052794Total Thyroxine (tT4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-09-01
04048474041095Free Thyroxine (fT4) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-08-31
04048474017816Total Thyroxine (T4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungKLI2023-08-26
00840239052797Total Thyroxine (tT4) ELISADRG International IncKLI2023-08-25
00894175000893AccuDiag ™Diagnostic Automation, Inc.KLI2023-06-14
06925912718512iFlash-T4Shenzhen YHLO Biotech Co., Ltd.KLI2022-10-26
00725609000649SPOTCHECKASTORIA-PACIFIC, INC.KLI2020-12-17
00850392007077BioCheck T4 EIA Test KitBIOCHECK, INC.KLI2019-10-08
00840239041098Free Thyroxine (fT4) ELISADRG International IncKLI2019-06-10
00840239017819Total Thyroxine (T4) ELISADRG International IncKLI2019-03-20
00380740131524AlinityABBOTT IRELANDKLI2018-12-04
00380740131517AlinityABBOTT IRELANDKLI2018-07-31
B24225TT4HUE010Total Thyroxine ELISA (Total T4 ELISA)AMERICAN LABORATORY PRODUCTS COMPANY, LTD.KLI2017-08-03
00884883005655CEDIA T4 AssayMicrogenics CorporationKLI2016-09-26
14560189210803ST AIA-PACK T4TOSOH CORPORATIONKLI2016-09-24
04560189211797AIA-PACK T4 SAMPLE DILUTING SOLUTIONTOSOH CORPORATIONKLI2016-09-24
04560189211803AIA-PACK T4 CALIBRATOR SETTOSOH CORPORATIONKLI2016-09-24
00842768005626Dimension® Flex® reagent cartridge T4Siemens Healthcare Diagnostics Inc.KLI2016-09-24
00857969006273ACEALFA WASSERMANN, INC.KLI2016-09-24
00630414954370IMMULITE®/IMMULITE® 1000 Systems T4 Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414966038IMMULITE® 2000 Systems TT4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414966229IMMULITE®/IMMULITE® 1000 Systems T4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00630414972992IMMULITE® 2000 Systems TT4 Total T4SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKLI2016-09-24
00884883004177DRI Thyroxine (T4)Microgenics CorporationKLI2016-09-22
04015630916016Total T4 Thyroxine)Roche Diagnostics GmbHKLI2016-09-20