FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge TAC

Primary DI
00842768035425
Brand
Dimension® Flex® reagent cartridge TAC
Company
Siemens Healthcare Diagnostics Inc.
Model
10700795
Catalog number
DF207
Device description
Tacrolimus Flex® reagent cartridge, TAC, 80 tests (4 x 20)
Published
2016-09-24
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
MLMENZYME IMMUNOASSAY, TRACROLIMUS

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150168000Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)Siemens Healthcare Diagnostics2015-11-04MLM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768035425PrimaryGS10
00630414005980Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768035425008427680354258427680354250842768035425
00630414005980006304140059806304140059800630414005980

GMDN Terms#

Term, Definition table
TermDefinition
Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug tacrolimus in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
4
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
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00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
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00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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