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

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