FDA.reportPublic FDA data

Synchron

Primary DI
15099590223335
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
474947
Catalog number
474947
Device description
Alcohol Reagent (ETOH 2 x 150)
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
DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DMTEnzymatic Method, Alcohol Dehydrogenase, UltravioletClinical 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
15099590223335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022333515099590223335

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen, using a spectrophotometry method. It is typically used to assess for alcohol intoxication and in the management of alcoholism.

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
06942284613443femometerJOYTECH HEALTHCARE CO.,LTDDMT2026-05-25
00380740135393AlinityABBOTT LABORATORIESDMT2019-04-16
00380740135386AlinityABBOTT LABORATORIESDMT2018-07-11
00884883012486DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-22
00884883001008DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-12
00884883002890DRI Ethyl Alcohol AssayMicrogenics CorporationDMT2016-09-12
00817302021851CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT KIT Product No. DT421CAROLINA LIQUID CHEMISTRIES CORPORATIONDMT2016-09-01
10758750004270VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DMT2016-08-23
00380740005559ARCHITECTABBOTT LABORATORIESDMT2016-06-06