FDA.reportPublic FDA data

Elecsys Tacrolimus

Primary DI
04015630947102
Brand
Elecsys Tacrolimus
Company
Roche Diagnostics GmbH
Model
05889057160
Catalog number
05889057160
Published
2019-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K173857000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173857000Elecsys TacrolimusRoche Diagnostics2018-11-06MLM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630947102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630947102040156309471024015630947102

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740154240AlinityAbbott Ireland DiagnosticsMLM2020-01-02
00380740154516AlinityAbbott Ireland DiagnosticsMLM2020-01-02
00380740168209Alinity-ArchitectABBOTT LABORATORIESMLM2019-06-14
04015630940271Elecsys TacrolimusRoche Diagnostics GmbHMLM2019-02-14
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