FDA.reportPublic FDA data

Alinity

Primary DI
00380740153892
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
09P3521
Catalog number
09P3521
Device description
Alinity i Anti-TPO Reagent Kit 200 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
JZOSYSTEM, TEST, THYROID AUTOANTIBODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZOSystem, Test, Thyroid AutoantibodyImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740153892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740153892003807401538923807401538920380740153892

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroid peroxidase (anti-TPO); also known as anti-microsomal antibody, 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
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00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414608754Atellica IM aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414608761Atellica IM aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414609492Atellica IM aTPOII DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414608570ADVIA Centaur aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
00630414608747ADVIA Centaur aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
00630414609409ADVIA Centaur aTPOII DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
15099590763527Access Thyroglobulin Antibody IIBeckman Coulter, Inc.JZO2023-12-01
07613336171479Elecsys Anti-TgRoche Diagnostics GmbHJZO2023-10-31
07613336203521Elecsys Anti-TgRoche Diagnostics GmbHJZO2023-10-31
04048474033694TSH Receptor Autoantibody ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJZO2023-08-29
00840239037084Anti TG Ab ELISADRG International IncJZO2023-08-25
00840239033697TSH Receptor Autoantibody ELISA DRG International IncJZO2023-08-24
00840239035615Anti TPO Ab ELISADRG International IncJZO2023-08-24
B3507204500Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test KitGold Standard Diagnostics CorporationJZO2022-12-03
B3507204600Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test KitGold Standard Diagnostics CorporationJZO2022-12-03
00813545026721MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545026738MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545026745MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545026752MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027148MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027155MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027162MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027179MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
07613336160305Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2020-04-14
07613336160329Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2020-04-14