FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740081911
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
1P06-02
Catalog number
01P0602
Device description
ARCHITECT Transplant Pretreatment Tubes
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKWCYCLOSPORINE
MLMENZYME IMMUNOASSAY, TRACROLIMUS
NRPSirolimus test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKWCyclosporineClinical Chemistry2
MLMEnzyme Immunoassay, TracrolimusClinical Chemistry2
NRPSirolimus Test SystemClinical Toxicology2

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
00380740081911PrimaryGS10
00380740138875Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740081911003807400819113807400819110380740081911
00380740138875003807401388753807401388750380740138875

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, K2EDTAA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening)]. 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
079226220
Device count
100
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03
00380740202835Alinity06P012506P01252025-10-03
00380740202859Alinity06P016106P01612025-10-03
00380740202996Alinity06P080706P08072025-09-17
00380740203023Alinity06P081506P08152025-09-17
00380740203030Alinity06P082506P08252025-09-17
00380740203054Alinity06P086106P08612025-09-17
00380740196257GLP systems Track04Z965104Z96512023-08-30
00380740225186ARCHITECT04P553004P55302026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00869164000079Emit Cyclosporine SampleFUJIREBIO DIAGNOSTICS, INC.MKW2023-12-06
00380740150990AlinityAbbott Ireland DiagnosticsNRP2020-05-05
00380740154233AlinityAbbott Ireland DiagnosticsNRP2020-05-05
00380740154240AlinityAbbott Ireland DiagnosticsMLM2020-01-02
00380740154516AlinityAbbott Ireland DiagnosticsMLM2020-01-02
00380740168209Alinity-ArchitectABBOTT LABORATORIESMLM2019-06-14
00380740168209Alinity-ArchitectABBOTT LABORATORIESNRP2019-06-14
00380740168209Alinity-ArchitectABBOTT LABORATORIESMKW2019-06-14
04015630940271Elecsys TacrolimusRoche Diagnostics GmbHMLM2019-02-14
04015630947102Elecsys TacrolimusRoche Diagnostics GmbHMLM2019-01-14
00630414238340Atellica CH TACRSiemens Healthcare Diagnostics Inc.MLM2018-10-08
00630414598727Atellica IM CsASiemens Healthcare Diagnostics Inc.MKW2018-02-06
00630414598741Atellica IM Multi-Diluent 12Siemens Healthcare Diagnostics Inc.MKW2018-02-06
00630414598765Atellica IM CsA PRE PretreatmentSiemens Healthcare Diagnostics Inc.MKW2018-02-06
00842768001451Syva® Emit® 2000 Cyclosporine Specific AssaySiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001468Syva® Emit® 2000 Cyclosporine Specific CalibratorsSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001475Syva® Emit® 2000 Cyclosporine Specific Negative CalibratorSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001482Syva® Emit® Cyclosporine Pretreatment ReagentSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001666Syva® Emit® 2000 Tacrolimus AssaySiemens Healthcare Diagnostics Inc.MLM2016-09-24
00842768005268Dimension® Flex® reagent cartridge CSAESiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768015144Dimension Vista® Flex® reagent cartridge CSASiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768016035Dimension Vista® Flex® reagent cartridge CSAESiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768018312Dimension® Flex® reagent cartridge TACRSiemens Healthcare Diagnostics Inc.MLM2016-09-24
00842768022111Dimension® Flex® reagent cartridge SIROSiemens Healthcare Diagnostics Inc.NRP2016-09-24
00842768025136Dimension® CSA Flex® reagent cartridgeSiemens Healthcare Diagnostics Inc.MKW2016-09-24
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
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
00884883011861CEDIA Cyclosporine-PLUS AssayMicrogenics CorporationMKW2016-09-24