FDA.reportPublic FDA data

ST AIA-PACK Homocysteine

Primary DI
14560189212777
Brand
ST AIA-PACK Homocysteine
Company
TOSOH CORPORATION
Model
N/A
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14560189212777PrimaryGS10
04560189212770Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1456018921277714560189212777
04560189212770045601892127704560189212770

GMDN Terms#

Term, Definition table
TermDefinition
Homocysteine IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of homocysteine 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
614-317-1909Levent.durukan@tosoh.com
650-615-8134Dave.Wurtz@tosoh.com

Regulatory Flags#

DUNS number
690571724
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14560189212081ST AIA-PACK 27.29N/A2026-02-02
04560189213418ST AIA-PACK PROG II CALIBRATOR SETN/A2026-02-02
04560189210172ST AIA-PACK 27.29N/A2026-02-02
04560189213395ST AIA-PACK PROG II CALIBRATOR SETN/A2019-07-11
14560189210179ST AIA-PACK 27.29N/A2016-09-24
04560189283503G7 Beta-Thalassemia Elution Buffer KitN/A2016-09-24
14560189210339ST AIA-PACK TT3N/A2019-07-25
14560189212135ST AIA-PACK T-UN/A2019-07-25
04560189211742AIA-PACK SUBSTRATE SET IIn/a2019-09-02
04560189212220AIA-PACK C-Peptide Control SetN/A2019-09-02
04560189212749ST AIA-PACK hsE2 CALIBRATOR SETN/A2019-07-24
04560189211759AIA-PACK WASH CONCENTRATEN/A2019-09-02
04560189211766AIA-PACK DILUENT CONCENTRATEN/A2019-09-02
14560189210056AIA-PACK TSH 3rd-GenN/A2016-09-24
14560189210063ST AIA-PACK BetaHCGN/A2016-09-24
14560189210094ST AIA-PACK MyoglobinN/A2016-09-24
14560189210155ST AIA-PACK IgEIIN/A2016-09-24
14560189210230ST AIA-PACK AFPN/A2016-09-24
14560189210261ST AIA-PACK BMGN/A2016-09-24
14560189210315ST AIA-PACK FT4N/A2016-09-24

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
04560189212817ST AIA-PACK Homocysteine Pretreatment SetTOSOH CORPORATIONLPS2016-09-24
05055273208894HCYRANDOX LABORATORIES LIMITEDLPS2016-09-24
00842768006128DImension Vista® Homocysteine Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHLPS2016-09-24
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