FDA.reportPublic FDA data

Alinity

Primary DI
00380740130060
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
08P3330
Catalog number
08P3330
Device description
Alinity i Cortisol Reagent Kit 1000 Tests
Published
2018-08-10
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
JFTFLUOROMETRIC, CORTISOL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFTFluorometric, CortisolClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740130060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740130060003807401300603807401300600380740130060

GMDN Terms#

Term, Definition table
TermDefinition
Total cortisol IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cortisol 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
985307301
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
00380740153953Alinity01R182101R18212019-01-04
00380740168742Alinity04W020104W02012025-12-11
00380740168759Alinity04W021004W02102025-12-11
00380740168780Alinity04W022204W02222025-12-11
00380740197742Alinity04W212704W21272025-10-14
00380740213893Alinity04W210204W21022025-10-14
00380740213909Alinity04W211204W21122025-10-14
00380740136772Alinity06P020406P02042019-09-14
00380740136789Alinity06P035906P03592019-09-14
00380740136796Alinity06P021306P02132019-09-14
00380740136802Alinity06P021506P02152019-09-14
00380740136819Alinity06P026006P02602019-09-14
00380740150990Alinity09P412009P41202020-05-05
00380740154233Alinity09P414009P41402020-05-05
00380740154240Alinity09P424009P42402020-01-02
00380740154516Alinity09P422009P42202020-01-02
00380740001339ARCHITECT1L76-0101L76012016-06-06
00380740001346ARCHITECT1L76-2501L76252016-06-06
00380740001353ARCHITECT1L76-5501L76552016-06-06
00380740001360ARCHITECT1L77-0101L77012016-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336180778Elecsys Cortisol IIIRoche Diagnostics GmbHJFT2025-07-24
00630414598666Atellica IM Cor MCMSiemens Healthcare Diagnostics Inc.JFT2020-09-24
00630414293608Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2020-05-31
00630414294155Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2020-05-31
00380740130053AlinityAbbott Ireland DiagnosticsJFT2018-08-10
04015630939985Elecsys Cortisol IIRoche Diagnostics GmbHJFT2018-06-06
00630414598642Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2018-02-06
00630414598659Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2018-02-06
00630414598673Atellica Cort Urine Recon BufferSiemens Healthcare Diagnostics Inc.JFT2018-02-06
14560189210735ST AIA-PACK CORTTOSOH CORPORATIONJFT2016-09-24
04560189211698AIA-PACK CORT Calibrator SetTOSOH CORPORATIONJFT2016-09-24
04560189211704AIA-PACK CORT Sample Diluting SolutionTOSOH CORPORATIONJFT2016-09-24
00630414121819ADVIA Centaur Cortisol Urine Reconstitution BufferSiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414524610ADVIA Centaur® COR +ESiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414524740ADVIA Centaur® COR MCMSiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414602943ADVIA Centaur® CORSiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414602950ADVIA Centaur® COR +ESiemens Healthcare Diagnostics Inc.JFT2016-09-24
04015630940677Elecsys Cortisol IIRoche Diagnostics GmbHJFT2016-09-20
03573026551469VIDAS® Serum FreeBIOMERIEUX SAJFT2016-08-31
03573026097295VIDAS® Serum FreeBIOMERIEUX SAJFT2016-08-31
00380740016258ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06
00380740016265ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06
00380740016272ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06