FDA.reportPublic FDA data

Synchron

Primary DI
15099590223342
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
474824
Catalog number
474824
Device description
Vancomycin Reagent (VANC 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
LEHRadioimmunoassay, Vancomycin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEHRadioimmunoassay, VancomycinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013076000SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATORBeckman Coulter, Inc.2001-12-12LEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590223342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022334215099590223342

GMDN Terms#

Term, Definition table
TermDefinition
Vancomycin therapeutic drug monitoring IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug vancomycin in a clinical specimen.

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
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
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336121627ONLINE TDM Vancomycin Gen.3Roche Diagnostics GmbHLEH2020-03-05
07613336157800ONLINE TDM Vancomycin Gen.3Roche Diagnostics GmbHLEH2020-03-05
00380740156237ARCHITECTAbbott GmbHLEH2020-03-03
00380740135348AlinityABBOTT LABORATORIESLEH2018-11-07
00630414596020Atellica CH VancSiemens Healthcare Diagnostics Inc.LEH2017-12-19
04015630934416ONLINE TDM Vancomyin Gen.3Roche Diagnostics GmbHLEH2016-10-13
04015630934447ONLINE TDM Vancomyin Gen.3Roche Diagnostics GmbHLEH2016-10-13
00842768001109Syva® Emit® 2000 Vancomycin AssaySiemens Healthcare Diagnostics Inc.LEH2016-09-24
00842768005763Dimension® Flex® reagent cartridge VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00842768015533Dimension Vista® Flex® reagent cartridge VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00842768023323Emit® 2000 Vancomycin AssaySiemens Healthcare Diagnostics Inc.LEH2016-09-24
00884883011182QMS Vancomycin ImmunoassayMicrogenics CorporationLEH2016-09-24
00630414121444ADVIA Centaur® Systems, ACS:180® Systems VANC CalibratorSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414121451ADVIA Centaur® Vancomycin CalibratorSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414126111ADVIA Centaur® VANC MCMSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414203928ADVIA Centaur® VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414443096ADVIA Centaur® VANCSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00630414561967ADVIA® Chemistry VANC_2 Vancomycin_2 ReagentsSiemens Healthcare Diagnostics Inc.LEH2016-09-24
00884883012837QMS Vancomycin ImmunoassayMicrogenics CorporationLEH2016-09-22
04015630915996VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630997978Vancomycin ONLINE TDM VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630998920VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630999392VancomycinRoche Diagnostics GmbHLEH2016-09-20
04015630997961Vancomycin ONLINE TDM VancomycinRoche Diagnostics GmbHLEH2016-09-20
10758750006731VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LEH2016-08-26
00884883011243QMS Vancomycin ImmunoassayMicrogenics CorporationLEH2016-08-26
00380740001711ARCHITECTAbbott GmbHLEH2016-06-06
00380740009847ARCHITECTABBOTT LABORATORIESLEH2016-06-06
00380740105327ARCHITECTAbbott GmbHLEH2016-06-06