FDA.reportPublic FDA data

AU

Primary DI
15099590020262
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR6279
Device description
CK (NAC)
Published
2016-09-24
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
CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGSNad Reduction/Nadh Oxidation, Cpk Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043202000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043202000OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279Olympus America, Inc.2004-12-23CGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590020262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959002026215099590020262

GMDN Terms#

Term, Definition table
TermDefinition
Total creatine kinase (CK) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total creatine kinase (CK) in a clinical specimen, using an enzyme spectrophotometry 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
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
00850053916090IDG/SanzayIDG/SANZAY CorporationCGS2024-01-09
10673486001648Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent SetTECO DIAGNOSTICSCGS2023-11-17
10673486001655Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent SetTECO DIAGNOSTICSCGS2023-11-17
10673486001495Teco Diagnostics Creatine Kinase (CK-NAC) Reagent SetTECO DIAGNOSTICSCGS2023-07-27
10673486001501Teco Diagnostics Creatine Kinase (CK-NAC) Reagent SetTECO DIAGNOSTICSCGS2023-07-27
10673486001594Teco Diagnostics Creatine Kinase (CK-NAC) Liquid ReagentTECO DIAGNOSTICSCGS2023-07-27
10673486001617Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent TC MatrixTECO DIAGNOSTICSCGS2023-07-27
00811727016096Pointe Creatine Kinase ReagentHORIBA INSTRUMENTS INCORPORATEDCGS2021-01-30
03610230006948Yumizen C1200 CK-NACHORIBA ABX SASCGS2020-08-31
00811727015785Pointe Creatine Kinase for BS480HORIBA INSTRUMENTS INCORPORATEDCGS2020-05-28
00380740161699ARCHITECTAbbott GmbHCGS2020-01-25
00380740161705ARCHITECTAbbott GmbHCGS2020-01-25
00380740132590AlinityAbbott GmbHCGS2019-05-07
00386100002183CK Reagent Kit MEDICA CORPORATIONCGS2019-02-14
00630414008943ADVIA Chemistry Creatine KinaseSiemens Healthcare Diagnostics Inc.CGS2018-11-12
00628063401079Creatine Kinase AssaySEKISUI DIAGNOSTICS, LLCCGS2018-09-24
00852169008089ClearChem Diagnostics Inc. Creatine Kinase (CK)CLEARCHEM DIAGNOSTICS INC.CGS2018-04-30
00630414006642Atellica CH CK_LSiemens Healthcare Diagnostics Inc.CGS2017-12-21
05060500091866Synermed®INFRARED LABORATORY SYSTEMS LLCCGS2017-02-28
00817302023039CAROLINA LIQUID CHEMISTRIES CORP.® CK REAGENT PRODUCT NO. DT207CAROLINA LIQUID CHEMISTRIES CORPORATIONCGS2016-10-17
00817302022940CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692CAROLINA LIQUID CHEMISTRIES CORPORATIONCGS2016-10-12
00812137011954CK-NAC Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.CGS2016-10-12
15099590010744AUBeckman Coulter, Inc.CGS2016-09-24
00842768025556Dimension® Flex® reagent cartridge MBISiemens Healthcare Diagnostics Inc.CGS2016-09-24
00842768027925Dimension Vista® Flex® reagent cartridge CKISiemens Healthcare Diagnostics Inc.CGS2016-09-24
00857969006075ACEALFA WASSERMANN, INC.CGS2016-09-24
00857969006143ACEALFA WASSERMANN, INC.CGS2016-09-24
00630414209746ADVIA® Chemistry CKNAC Creatine Kinase ReagentsSiemens Healthcare Diagnostics Inc.CGS2016-09-24
00630414508337ADVIA® Chemistry CKNAC Creatine Kinase ReagentsSiemens Healthcare Diagnostics Inc.CGS2016-09-24
00015482771027SPOTCHEM™ II Uric AcidARKRAY USA, INC.CGS2016-09-23