FDA.reportPublic FDA data

Alinity

Primary DI
00380740135478
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
08P1210
Catalog number
08P1210
Device description
Alinity i T-Uptake Controls
Published
2018-10-22
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
JJXSingle (specified) analyte controls (assayed and unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740135478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740135478003807401354783807401354780380740135478

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid uptake (T-uptake) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative determination of thyroid hormone uptake (T-uptake), or the unbound/free portion of thyroxine binding globulin (TBG) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
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
Premarket exempt
true
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
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23