FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge TOBR

Primary DI
00842768015472
Brand
Dimension Vista® Flex® reagent cartridge TOBR
Company
Siemens Healthcare Diagnostics Inc.
Model
10445121
Catalog number
K4014
Device description
Tobramycin Flex® reagent cartridge, 40 tests
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
LCRFLUORESCENT IMMUNOASSAY, TOBRAMYCIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCRFluorescent Immunoassay, TobramycinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061655000DIMENSION VISTA FLEX REAGENT CARTRIDGESDade Behring, Inc.2006-07-10LDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015472PrimaryGS10
00630414004945Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015472008427680154728427680154720842768015472
00630414004945006304140049456304140049450630414004945

GMDN Terms#

Term, Definition table
TermDefinition
Tobramycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryA 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 a nephelometry/turbidimetry 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)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414595962Atellica CH TobSiemens Healthcare Diagnostics Inc.LCR2017-12-22
00884883011328QMS Tobramycin Immunoassay Calibrator SetMicrogenics CorporationLCR2016-10-25
00842768005381Dimension® Flex® reagent cartridge TOBRSiemens Healthcare Diagnostics Inc.LCR2016-09-24
00884883012691QMS Tobramycin AssayMicrogenics CorporationLCR2016-09-12
15099590222185SynchronBeckman Coulter, Inc.LCR2016-08-24
00380740013127ARCHITECTABBOTT LABORATORIESLCR2016-06-06
00817470009521VENTERASmith & Nephew, Inc.LCR2015-12-06