FDA.reportPublic FDA data

Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent

Primary DI
00842768030048
Brand
Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent
Company
Siemens Healthcare Diagnostics Inc.
Model
10488260
Catalog number
8S079UL
Device description
Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent
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
NRPSirolimus test system

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083487000EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATORSiemens Healthcare Diagnostics2009-03-30NRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768030048PrimaryGS10
00630414010526Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768030048008427680300488427680300480842768030048
00630414010526006304140105266304140105260630414010526

GMDN Terms#

Term, Definition table
TermDefinition
Multiple immunosuppressant 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 multiple immunosuppressant drugs which may include cyclosporin A (or cyclosporine), tacrolimus, sirolimus and/or everolimus, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740150990AlinityAbbott Ireland DiagnosticsNRP2020-05-05
00380740154233AlinityAbbott Ireland DiagnosticsNRP2020-05-05
00380740154240AlinityAbbott Ireland DiagnosticsMLM2020-01-02
00380740154516AlinityAbbott Ireland DiagnosticsMLM2020-01-02
00380740168209Alinity-ArchitectABBOTT LABORATORIESNRP2019-06-14
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
00842768022111Dimension® Flex® reagent cartridge SIROSiemens Healthcare Diagnostics Inc.NRP2016-09-24
00842768029615Syva® Emit® 2000 Sirolimus AssaySiemens Healthcare Diagnostics Inc.NRP2016-09-24
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
00380740081911ARCHITECTABBOTT LABORATORIESNRP2016-09-09
00380740001339ARCHITECTAbbott Ireland DiagnosticsNRP2016-06-06
00380740001346ARCHITECTAbbott Ireland DiagnosticsNRP2016-06-06
00380740001353ARCHITECTAbbott Ireland DiagnosticsNRP2016-06-06
00380740001360ARCHITECTAbbott Ireland DiagnosticsMLM2016-06-06
00380740001377ARCHITECTAbbott Ireland DiagnosticsMLM2016-06-06
00380740001384ARCHITECTAbbott Ireland DiagnosticsMLM2016-06-06