FDA.reportPublic FDA data

Syva® Emit® 2000 Tobramycin Assay

Primary DI
00842768001062
Brand
Syva® Emit® 2000 Tobramycin Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10445330
Catalog number
4S019UL
Device description
Syva® Emit® 2000 Tobramycin Assay
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
KLBRADIOIMMUNOASSAY, TOBRAMYCIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLBRadioimmunoassay, TobramycinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003341000EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORSSyva Co., Dade Behring, Inc.2001-01-22KLB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768001062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768001062008427680010628427680010620842768001062

GMDN Terms#

Term, Definition table
TermDefinition
Tobramycin 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 antimicrobial drug tobramycin 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

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
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
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00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336147948ONLINE TDM TobramycinRoche Diagnostics GmbHKLB2020-03-05
00842768023309Emit® 2000 Tobramycin AssaySiemens Healthcare Diagnostics Inc.KLB2016-09-24
00630414561677ADVIA® Chemistry TOB_2 Tobramycin_2 ReagentsSiemens Healthcare Diagnostics Inc.KLB2016-09-24
04015630997930Tobramycin ONLINE TDM TobramycinRoche Diagnostics GmbHKLB2016-09-20
04015630998999TobramycinRoche Diagnostics GmbHKLB2016-09-20