FDA.reportPublic FDA data

Alinity

Primary DI
00380740150990
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
09P4120
Catalog number
09P4120
Device description
Alinity i Sirolimus Reagent Kit 200 Tests
Published
2020-05-05
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
NRPSirolimus test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRPSirolimus Test SystemClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070822000ARCHITECT SIROLIMUS ASSAYFujirebio Diagnostics,Inc.2007-09-28NRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740150990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740150990003807401509903807401509900380740150990

GMDN Terms#

Term, Definition table
TermDefinition
Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug rapamycin (sirolimus) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
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
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
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
00380740001377ARCHITECT1L77-2501L77252016-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740154233AlinityAbbott Ireland DiagnosticsNRP2020-05-05
00380740168209Alinity-ArchitectABBOTT LABORATORIESNRP2019-06-14
00842768022111Dimension® Flex® reagent cartridge SIROSiemens Healthcare Diagnostics Inc.NRP2016-09-24
00842768029615Syva® Emit® 2000 Sirolimus AssaySiemens Healthcare Diagnostics Inc.NRP2016-09-24
00842768030048Syva® Emit® 2000 Siro/Tacro Sample Pretreatment ReagentSiemens Healthcare Diagnostics Inc.NRP2016-09-24
00380740081911ARCHITECTABBOTT LABORATORIESNRP2016-09-09
00380740001339ARCHITECTAbbott Ireland DiagnosticsNRP2016-06-06
00380740001346ARCHITECTAbbott Ireland DiagnosticsNRP2016-06-06
00380740001353ARCHITECTAbbott Ireland DiagnosticsNRP2016-06-06