FDA.reportPublic FDA data

Synchron

Primary DI
15099590232061
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
469137
Catalog number
469137
Device description
Gentamicin Reagent (GEN 2 x 100)
Published
2016-08-24
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955644000SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEMBeckman Instruments, Inc.1996-02-16KLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590232061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023206115099590232061

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16

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
04015630994939CEDIA Gentamicin IIRoche Diagnostics GmbHLCD2016-09-20
00380740001735ARCHITECTAbbott GmbHLCD2016-09-09
00380740001742ARCHITECTAbbott GmbHLCD2016-09-09
10758750006755VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LCD2016-08-10
00380740000301ARCHITECTABBOTT LABORATORIESLCD2016-06-06