Synchron

Primary DI
15099590222079
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
474994
Catalog number
474994
Device description
SYNCHRON Systems ETOH Calibrator
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
DNNCalibrators, Ethyl Alcohol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DNNCalibrators, Ethyl AlcoholClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000410000SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORSBeckman Coulter, Inc.2000-04-10DMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590222079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022207915099590222079

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
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
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
00811727017413Pointe Ethyl Alcohol Calibrator (100 mg/dL)HORIBA INSTRUMENTS INCORPORATEDDNN2020-09-25
04250317536754Urine Calibrator SetChromsystems Instruments + Chemicals GmbHDNN2019-03-22
00380740135355AlinityABBOTT LABORATORIESDNN2018-07-11
00852553007247Ethanol Standard KitVERICHEM LABORATORIES, INC.DNN2018-01-16
00852553007346Ethanol Standard, Level DVERICHEM LABORATORIES, INC.DNN2018-01-16
00884883005129DRI Negative Alcohol CalibratorMicrogenics CorporationDNN2016-09-12
00884883005198DRI 100 mg/dL Alcohol Calibrator Microgenics CorporationDNN2016-09-12
00884883011540DRI 100 mg/dL Alcohol Calibrator Microgenics CorporationDNN2016-09-12
00884883011564DRI Negative Alcohol CalibratorMicrogenics CorporationDNN2016-09-12
00817302021332CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00817302021349CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00817302021356CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00817302021363CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00817302021370CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00817302021387CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421CAROLINA LIQUID CHEMISTRIES CORPORATIONDNN2016-09-01
00811727010087POINTE SCIENTIFIC Alcohol StandardHORIBA INSTRUMENTS INCORPORATEDDNN2016-08-31
10758750005048VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DNN2016-08-23
B07602230Ethyl Alcohol DAU Calibrator, Calibrator #2LIN-ZHI INTERNATIONAL, INC.DNN2016-07-05
00380740005511ARCHITECTABBOTT LABORATORIESDNN2016-06-06
00380740005528ARCHITECTABBOTT LABORATORIESDNN2016-06-06
00380740005535ARCHITECTABBOTT LABORATORIESDNN2016-06-06
00380740005542ARCHITECTABBOTT LABORATORIESDNN2016-06-06