FDA.reportPublic FDA data

Alinity

Primary DI
00380740153496
Brand
Alinity
Company
Abbott GmbH
Model
09P2820
Catalog number
09P2820
Device description
Alinity i Homocysteine Reagent Kit 200 Tests
Published
2018-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00380740153496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740153496003807401534963807401534960380740153496

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 Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

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
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
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