FDA.reportPublic FDA data

CEDIA Gentamicin II

Primary DI
04015630994939
Brand
CEDIA Gentamicin II
Company
Roche Diagnostics GmbH
Model
11815342216
Catalog number
11815342216
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LCDENZYME IMMUNOASSAY, GENTAMICIN

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630994939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630994939040156309949394015630994939

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

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
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
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