FDA.reportPublic FDA data

Alinity

Primary DI
00380740129613
Brand
Alinity
Company
ABBOTT LABORATORIES
Model
03R0101
Catalog number
03R0101
Device description
Alinity s Sample Cups
Published
2019-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00380740129613PrimaryGS10
00380740177881Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740129613003807401296133807401296130380740129613
00380740177881003807401778813807401778810380740177881

GMDN Terms#

Term, Definition table
TermDefinition
Assay container IVD, single-useA non-sterile reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
828079900
Device count
200
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740136963Alinity07P810407P81042023-11-16
00380740136994Alinity07P830107P83012023-11-16
00380740137007Alinity07P800407P80042023-11-16
00380740137021Alinity07P790407P79042023-11-16
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06

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
00380740162894AlinityAbbott GmbHMZA2019-09-28
00380740162924AlinityAbbott GmbHMZA2019-09-14
00380740162931AlinityAbbott GmbHMZA2019-09-14
00380740162948AlinityAbbott GmbHMZA2019-09-14
00380740118181AlinityAbbott Ireland DiagnosticsMZA2019-07-26
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