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Dimension Vista® Flex® reagent cartridge GENT

Primary DI
00842768015212
Brand
Dimension Vista® Flex® reagent cartridge GENT
Company
Siemens Healthcare Diagnostics Inc.
Model
10445120
Catalog number
K4012
Device description
Gentamicin 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
LCDENZYME IMMUNOASSAY, GENTAMICIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCDEnzyme Immunoassay, GentamicinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062024000DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGEDade Behring, Inc.2006-07-28LFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768015212PrimaryGS10
00630414004938Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015212008427680152128427680152120842768015212
00630414004938006304140049386304140049380630414004938

GMDN Terms#

Term, Definition table
TermDefinition
Gentamicin 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 gentamicin 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

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740193645ARCHITECTAbbott GmbHLCD2026-04-28
07613336190807CEDIA Gentamicin II (GENTC)Microgenics CorporationLCD2020-06-23
00884883007123GENTCMicrogenics CorporationLCD2019-11-20
00380740135522AlinityABBOTT LABORATORIESLCD2018-12-31
00630414595979Atellica CH GentSiemens Healthcare Diagnostics Inc.LCD2017-12-21
05055273206449GENTRANDOX LABORATORIES LIMITEDLCD2016-09-24
00842768001086Syva® Emit® 2000 Gentamicin Plus AssaySiemens Healthcare Diagnostics Inc.LCD2016-09-24
00842768001093Syva® Emit® 2000 Gentamicin Plus CalibratorsSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00842768005336Dimension® Flex® reagent cartridge GENTSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00842768023316Emit® 2000 Gentamicin Plus AssaySiemens Healthcare Diagnostics Inc.LCD2016-09-24
00884883001312CEDIA Gentamicin II AssayMicrogenics CorporationLCD2016-09-24
00884883012677QMS Gentamicin AssayMicrogenics CorporationLCD2016-09-24
00630414527277ADVIA Centaur® GENTSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00630414527284ADVIA Centaur® Systems, ACS:180® Systems GENT CalibratorSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00630414527291ADVIA Centaur® Systems Gentamicin CalibratorSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00630414527307ADVIA Centaur® Gentamicin MCMSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00630414561943ADVIA® Chemistry GENT_2 Gentamicin_2 ReagentsSiemens Healthcare Diagnostics Inc.LCD2016-09-24
00884883011205QMS Gentamycin ImmunoassayMicrogenics CorporationLCD2016-09-22
04015630994939CEDIA Gentamicin IIRoche Diagnostics GmbHLCD2016-09-20
00380740001735ARCHITECTAbbott GmbHLCD2016-09-09
00380740001742ARCHITECTAbbott GmbHLCD2016-09-09
15099590232061SynchronBeckman Coulter, Inc.LCD2016-08-24
10758750006755VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LCD2016-08-10
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