FDA.reportPublic FDA data

Alinity

Primary DI
00380740162894
Brand
Alinity
Company
Abbott GmbH
Model
06P045A
Catalog number
06P045A
Device description
Alinity s Anti-HCV e-Assay File
Published
2019-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZATest, equipment, automated bloodborne pathogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZATest, Equipment, Automated Bloodborne PathogenUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740162894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740162894003807401628943807401628940380740162894

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315786293
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336206355cobas® 6800 systemRoche Molecular Systems, Inc.MZA2026-03-26
07613336206362cobas® 8800 systemRoche Molecular Systems, Inc.MZA2026-03-26
00380740157166AlinityAbbott Ireland DiagnosticsMZA2024-07-18
00380740157173AlinityAbbott Ireland DiagnosticsMZA2024-07-18
00380740198930AlinityAbbott GmbHMZA2024-01-17
00380740162887AlinityAbbott GmbHMZA2019-11-30
00380740162863AlinityAbbott GmbHMZA2019-10-12
00380740162917AlinityAbbott GmbHMZA2019-10-12
00380740162924AlinityAbbott GmbHMZA2019-09-14
00380740162931AlinityAbbott GmbHMZA2019-09-14
00380740162948AlinityAbbott GmbHMZA2019-09-14
00380740118181AlinityAbbott Ireland DiagnosticsMZA2019-07-26
00380740129613AlinityABBOTT LABORATORIESMZA2019-07-26
00380740136895AlinityAbbott Ireland DiagnosticsMZA2019-07-26
00380740138479AlinityABBOTT LABORATORIESMZA2019-07-26
00380740156817AlinityABBOTT LABORATORIESMZA2019-07-26
00380740156831AlinityABBOTT LABORATORIESMZA2018-10-03
00380740118167AlinityAbbott Ireland DiagnosticsMZA2018-05-31
00380740118174AlinityAbbott Ireland DiagnosticsMZA2018-05-31
00380740129026AlinityABBOTT LABORATORIESMZA2018-05-31
00380740132705AlinityABBOTT LABORATORIESMZA2018-05-31
00380740007904ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
00380740007911ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
00380740012403ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
00380740050375ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
10758750005352ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750005420ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750005451ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750005581ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750007523ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24