FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge FT4

Primary DI
00842768015205
Brand
Dimension Vista® Flex® reagent cartridge FT4
Company
Siemens Healthcare Diagnostics Inc.
Model
10445103
Catalog number
K6410
Device description
Free Thyroxine Flex® reagent cartridge, 200 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
CECRADIOIMMUNOASSAY, FREE THYROXINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CECRadioimmunoassay, Free ThyroxineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140859000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140859000DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENTSiemens Healthcare Diagnostics, Inc.2014-11-26CEC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015205PrimaryGS10
00630414004778Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015205008427680152058427680152050842768015205
00630414004778006304140047786304140047780630414004778

GMDN Terms#

Term, Definition table
TermDefinition
Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen, using a chemiluminescent immunoassay 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
00630414482446ADVIA® Chemistry LIP Lipase Reagents10311896103118962020-09-24
00630414510149ADVIA® Chemistry CHE Cholinesterase Reagents10315176103151762020-09-24
00630414526829ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent10335892103358922020-09-24
00630414553191ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated10283347102833472020-09-24
00842768013713Dimension® CTNI Calibrator10444986104449862016-09-24
00842768016936Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge10444901104449012016-09-24
00630414482385ADVIA® Chemistry RF Rheumatoid Factor Reagents10311894103118942016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)10316612103166122016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
00630414601199ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator10916060109160602016-09-24
00630414947419ADVIA® Chemistry Albumin BCP Reagents10711841107118412016-09-24
00630414947426ADVIA® Chemistry Albumin BCP Calibrator10711842107118422016-09-24
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590780982Access Free T4Beckman Coulter, Inc.CEC2024-03-12
00850049545990QMedix™Diagnostic Automation, Inc.CEC2024-02-02
04048474042665Free Thyroxine (fT4) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEC2023-08-31
00894175000923AccuDiag ™Diagnostic Automation, Inc.CEC2023-06-14
07613336175071Elecsys FT4 IVRoche Diagnostics GmbHCEC2023-05-03
07613336172780Elecsys FT4 IVRoche Diagnostics GmbHCEC2023-05-02
06947145577971MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
06947145577988MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.CEC2022-08-02
00630414293851Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-12-12
00630414294292Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-12-12
00630414599144Atellica IM FT4 MCMSiemens Healthcare Diagnostics Inc.CEC2020-09-24
00630414293684Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-05-31
00630414294193Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2020-05-31
00840239042668Free Thyroxine (fT4) ELISADRG International IncCEC2019-06-10
00816870021713Free T4 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CEC2019-02-11
00816870021720Free T4 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CEC2019-02-11
00816870021737Monobind AccuBind Free T4 ELISA Kit - 480 WellsMONOBIND, INC.CEC2019-02-11
00816870021744Free T4 AccuBind ELISA Test System - 960 WellsMONOBIND, INC.CEC2019-02-11
00816870023151Free T4 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CEC2019-02-11
00816870023168Free T4 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CEC2019-02-11
00816870023175Free T4 AccuLite CLIA Test System - 480 WellsMONOBIND, INC.CEC2019-02-11
00816870023182Monobind AccuLite Free T4 CLIA Kit - 960 WellsMONOBIND, INC.CEC2019-02-11
00380740121822AlinityABBOTT IRELANDCEC2018-07-31
00380740121815AlinityABBOTT IRELANDCEC2018-05-31
00380740119799ARCHITECTABBOTT IRELANDCEC2018-05-14
00380740119805ARCHITECTABBOTT IRELANDCEC2018-05-14
00380740119812ARCHITECTABBOTT IRELANDCEC2018-05-14
08809317540382FREND Free T4NanoEnTek, Inc.CEC2018-05-04
00630414599120Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2018-02-06
00630414599137Atellica IM FT4Siemens Healthcare Diagnostics Inc.CEC2018-02-06