FDA.reportPublic FDA data

Alinity

Primary DI
00380740154240
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
09P4240
Catalog number
09P4240
Device description
Alinity i Tacrolimus Whole Blood Precipitation Reagent 1 Tests
Published
2020-01-02
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
MLMENZYME IMMUNOASSAY, TRACROLIMUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLMEnzyme Immunoassay, TracrolimusClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070820000ARCHITECT TACROLIMUS: MODEL 1L77Fujirebio Diagnostics,Inc.2007-08-01MLM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740154240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740154240003807401542403807401542400380740154240

GMDN Terms#

Term, Definition table
TermDefinition
Tacrolimus therapeutic drug monitoring IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug tacrolimus in a clinical specimen.

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
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
00380740150990Alinity09P412009P41202020-05-05
00380740154233Alinity09P414009P41402020-05-05
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
00380740154516AlinityAbbott Ireland DiagnosticsMLM2020-01-02
00380740168209Alinity-ArchitectABBOTT LABORATORIESMLM2019-06-14
04015630940271Elecsys TacrolimusRoche Diagnostics GmbHMLM2019-02-14
04015630947102Elecsys TacrolimusRoche Diagnostics GmbHMLM2019-01-14
00630414238340Atellica CH TACRSiemens Healthcare Diagnostics Inc.MLM2018-10-08
00842768001666Syva® Emit® 2000 Tacrolimus AssaySiemens Healthcare Diagnostics Inc.MLM2016-09-24
00842768018312Dimension® Flex® reagent cartridge TACRSiemens Healthcare Diagnostics Inc.MLM2016-09-24
00842768030048Syva® Emit® 2000 Siro/Tacro Sample Pretreatment ReagentSiemens Healthcare Diagnostics Inc.MLM2016-09-24
00842768035425Dimension® Flex® reagent cartridge TACSiemens Healthcare Diagnostics Inc.MLM2016-09-24
00816776020001MassTrak™WATERS TECHNOLOGIES CORPORATIONMLM2016-09-24
00884883011830QMS Tacrolimus ImmunoassayMicrogenics CorporationMLM2016-09-22
00380740081911ARCHITECTABBOTT LABORATORIESMLM2016-09-09
00380740001360ARCHITECTAbbott Ireland DiagnosticsMLM2016-06-06
00380740001377ARCHITECTAbbott Ireland DiagnosticsMLM2016-06-06
00380740001384ARCHITECTAbbott Ireland DiagnosticsMLM2016-06-06