FDA.reportPublic FDA data

Alinity

Primary DI
00380740215712
Brand
Alinity
Company
ABBOTT LABORATORIES
Model
03R6584
Catalog number
03R6584
Device description
Alinity i Processing Module, refurbished
Published
2025-10-08
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
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CFRHEXOKINASE, GLUCOSE
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
JGSELECTRODE, ION SPECIFIC, SODIUM
JJEAnalyzer, chemistry (photometric, discrete), for clinical use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CFRHexokinase, GlucoseClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740215712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740215712003807402157123807402157120380740215712

GMDN Terms#

Term, Definition table
TermDefinition
Chemiluminescent immunoassay analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software.

Contacts#

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

Regulatory Flags#

DUNS number
117245596
Device count
1
Serial number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740225186ARCHITECT04P553004P55302026-05-14
00380740225193ARCHITECT04P573304P57332026-05-14
00380740003197ARCHITECT2K41-1002K41102016-06-06
00380740138851Alinity09P680109P68012023-11-16
00380740138868Alinity09P690109P69012023-11-16
00380740203191Alinity06P023006P02302025-09-24
00380740203214Alinity06P020606P02062025-09-24
00380740203238Alinity06P022006P02202025-09-24
00380740203252Alinity06P026106P02612025-09-24
00380740203276Alinity06P035806P03582025-09-24
00380740202958Alinity06P060706P06072025-09-24
00380740203061Alinity06P061506P06152025-09-24
00380740203078Alinity06P062506P06252025-09-24
00380740203092Alinity06P066106P06612025-09-24
00380740023386ARCHITECT03M740103M74012026-01-24
00380740225155ARCHITECT04J622804J62282026-01-03
00380740225162ARCHITECT08G982808G98282026-01-03
00380740224523ARCHITECT04P552804P55282026-01-01
00380740224530ARCHITECT04P573204P57322026-01-01
00380740213565Alinity09P680209P68022025-12-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740225186ARCHITECTABBOTT LABORATORIESJJE2026-05-14
00380740225193ARCHITECTABBOTT LABORATORIESJJE2026-05-14
07613336224397cobas ISE neo 1800 analytical unitRoche Diagnostics GmbHJJE2026-04-03
20612479280124McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
00380740223700ARCHITECTABBOTT LABORATORIESJJE2025-11-08
00380740223717ARCHITECTABBOTT LABORATORIESJJE2025-11-08
00380740186524AlinityAbbott GmbHJJE2025-10-24
00380740023089ARCHITECTABBOTT LABORATORIESJJE2025-10-17
00380740194765AlinityAbbott GmbHJJE2025-10-14
20612479279715McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-09-10
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJJE2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJJE2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJJE2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJJE2025-05-28
10758750034291VITROSORTHO CLINICAL DIAGNOSTICSDHA2024-09-18
00380740157173AlinityAbbott Ireland DiagnosticsJJE2024-07-18
00380740214487ARCHITECTABBOTT LABORATORIESJJE2024-07-11
00380740196257GLP systems TrackABBOTT LABORATORIESJJE2023-08-30
10758750031658VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CGZ2023-04-28
15099590744380Access Total BhCG (5th IS)Beckman Coulter, Inc.DHA2023-01-06
00380740195205AlinityAbbott GmbHJJE2023-01-06
00380740204082ARCHITECTABBOTT LABORATORIESJJE2023-01-06
00380740195458AlinityAbbott GmbHJJE2022-09-16
00380740202231ARCHITECTABBOTT LABORATORIESJJE2022-09-16
00380740202248ARCHITECTABBOTT LABORATORIESJJE2022-09-16
08806388243310Multi-unit Angled AbutmentMegagen Implant Co. LtdDHA2021-11-17
08033622964544EnvoyBIOTECNICA INSTRUMENTS SPAJJE2020-09-18
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGZ2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01