FDA.reportPublic FDA data

DImension Vista® Homocysteine Flex® reagent cartridge

Primary DI
00842768006128
Brand
DImension Vista® Homocysteine Flex® reagent cartridge
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445897
Catalog number
K7044
Device description
For the quantitative measurement of total homocysteine in human serum and plasma on the Dimension Vista® System
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
LPSURINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPSUrinary Homocystine (Nonquantitative) Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063206000DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.2006-12-28LPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768006128PrimaryGS10
00842768020032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768006128008427680061288427680061280842768006128
00842768020032008427680200328427680200320842768020032

GMDN Terms#

Term, Definition table
TermDefinition
Homocysteine IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of homocysteine in a clinical specimen.

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
388240673
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817089021464DiazymeDIAZYME LABORATORIES, INC.LPS2020-07-21
00811727015877Pointe Homocysteine for BS480HORIBA INSTRUMENTS INCORPORATEDLPS2020-05-28
07613336121290Homocysteine Enzymatic AssayRoche Diagnostics GmbHLPS2020-03-16
00380740153496AlinityAbbott GmbHLPS2018-12-04
00630414599298Atellica IM HCYSiemens Healthcare Diagnostics Inc.LPS2018-02-06
00630414599304Atellica IM HCYSiemens Healthcare Diagnostics Inc.LPS2018-02-06
00630414599311Atellica IM HCY DILSiemens Healthcare Diagnostics Inc.LPS2018-02-06
00630414599328Atellica IM HCY MCMSiemens Healthcare Diagnostics Inc.LPS2018-02-06
00380740156527ARCHITECTAbbott GmbHLPS2018-01-03
00817089020306DiazymeDIAZYME LABORATORIES, INC.LPS2016-11-03
00817089020948DiazymeDIAZYME LABORATORIES, INC.LPS2016-11-03
00817089020955DiazymeDIAZYME LABORATORIES, INC.LPS2016-11-03
00817439020918MedTest DX HomocysteineMedtest Dx, Inc.LPS2016-09-30
00817439020925MedTest DX Homocysteine ControlsMedtest Dx, Inc.LPS2016-09-30
14560189212777ST AIA-PACK HomocysteineTOSOH CORPORATIONLPS2016-09-24
04560189212817ST AIA-PACK Homocysteine Pretreatment SetTOSOH CORPORATIONLPS2016-09-24
05055273208894HCYRANDOX LABORATORIES LIMITEDLPS2016-09-24
00842768006715N Latex HCYSiemens Healthcare Diagnostics Products GmbHLPS2016-09-24
00630414468174ADVIA Centaur® HCYSiemens Healthcare Diagnostics Inc.LPS2016-09-24
00630414468181ADVIA Centaur® HCYSiemens Healthcare Diagnostics Inc.LPS2016-09-24
00630414468211ADVIA Centaur® HCY DILSiemens Healthcare Diagnostics Inc.LPS2016-09-24
00630414468235ADVIA Centaur® HCY MCMSiemens Healthcare Diagnostics Inc.LPS2016-09-24
00630414953892IMMULITE® 2000 Systems HCY Homocysteine Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLPS2016-09-24
00630414961620IMMULITE® 2000 Systems HCY HomocysteineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLPS2016-09-24
00630414964157IMMULITE®/IMMULITE® 1000 Systems HCY HomocysteineSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLPS2016-09-24
08426950453024HemosIL HomocysteineINSTRUMENTATION LABORATORY COMPANYLPS2016-09-23
04015630927326Homocysteine Enzymatic AssayRoche Diagnostics GmbHLPS2016-09-20
04015630929979Homocysteine Enzymatic AssayRoche Diagnostics GmbHLPS2016-09-20
04015630933631Homocysteine Enzymatic AssayRoche Diagnostics GmbHLPS2016-09-20
00817302020014CAROLINA LIQUID CHEMISTRIES CORP. ® HCY RGT. KIT BL-201CAROLINA LIQUID CHEMISTRIES CORPORATIONLPS2016-09-01