FDA.reportPublic FDA data

Alere NT-proBNP for Alinity Control Kit

Primary DI
05055845400527
Brand
Alere NT-proBNP for Alinity Control Kit
Company
AXIS-SHIELD DIAGNOSTICS LIMITED
Model
04S7911
Catalog number
04S7911
Device description
The Alere NT-proBNP for Alinity i Controls are for the estimation of test precision and the detection of systematic analytical deviations of the Alinity i analyzer when used for the quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma.For additional information, refer to the Alere NT-proBNP for Alinity i reagent package insert and the Alinity ci-series Operations Manual.
Published
2025-02-27
Public version status
New
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
05055845400527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055845400527050558454005275055845400527

GMDN Terms#

Term, Definition table
TermDefinition
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-441-7440USProductsupport@abbott.com

Regulatory Flags#

DUNS number
229062427
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055845400596Alere NT-proBNP for Alinity Reagent Kit (200 Tests)04S792104S79212025-02-26
05055845400497Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIAFCCP600FCCP6002019-08-02
05055845400008Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIAFCCP600FCCP6002016-09-01
05055845400015Axis® Homocysteine EIAFHCY100FHCY1002016-06-13
05055845400022Axis-Shield Homocysteine ControlsFHCY200FHCY2002016-07-01
05055845400046Axis-Shield Active-B12 (Holotranscobalamin) EIAFMABT100FMABT1002016-09-02
050558454000843-Reagent Homocysteine Assay for SYNCHRON UniCelFHYB100/B08175FHYB100/B081752016-07-01
05055845400169Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR100FHRWR1002016-07-01
05055845400176Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR200FHRWR2002016-07-01
05055845400183Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR1000FHRWR10002016-07-01
05055845400282Axis-Shield Liquid Stable (LS) 2-Part Homocysteine ReagentFHBC100/B08176FHBC100/B081762016-07-01
05055845400534Alere NT-proBNP for Alinity Calibrator Kit04S790204S79022025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
14987481164489uTASWako DCP Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164496uTASWako DCP Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21