FDA.reportPublic FDA data

GENT

Primary DI
05055273206449
Brand
GENT
Company
RANDOX LABORATORIES LIMITED
Model
TD3413
Catalog number
TD3413
Device description
For the quantitative in vitro determination of Gentamicin in human serum
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K012978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012978000RANDOX GENTAMICINRandox Laboratories, Ltd.2001-09-18LCD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273206449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273206449050552732064495055273206449

GMDN Terms#

Term, Definition table
TermDefinition
Gentamicin 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 gentamicin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

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
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
00842768015212Dimension Vista® 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
00380740000301ARCHITECTABBOTT LABORATORIESLCD2016-06-06