FDA.reportPublic FDA data

AU

Primary DI
15099590011468
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR61155
Device description
CK-MB
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
JHYColorimetric Method, Cpk Or Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHYColorimetric Method, Cpk Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070835000OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (Irish2007-06-04JHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590011468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959001146815099590011468

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) 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
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
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870020655CK-MB AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JHY2019-02-11
00816870020662CK-MB AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JHY2019-02-11
00816870022338Monobind AccuLite CKMB CLIA Kit - 96 WellsMONOBIND, INC.JHY2019-02-11
00816870022345CK-MB AccuLite CLIA Test System - 192 WellsMONOBIND, INC.JHY2019-02-11
04015630939978Elecsys CK-MBRoche Diagnostics GmbHJHY2017-04-21
04015630939534CalSet CK-MBRoche Diagnostics GmbHJHY2017-04-17
M525552612SPIFE CK-20,40 Gel KitHELENA LABORATORIES CORPORATIONJHY2017-02-10
00842768013829Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.JHY2016-09-24
00842768013898Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.JHY2016-09-24
00842768015328Dimension Vista® Flex® reagent cartridge MMBSiemens Healthcare Diagnostics Inc.JHY2016-09-24
04015630928729Elecsys CKMB STAT CalSetRoche Diagnostics GmbHJHY2016-09-20
04015630934638Elecsys CKMB STAT ImmunoassayRoche Diagnostics GmbHJHY2016-09-20
04015630934621Elecsys CKMB ImmunoassayRoche Diagnostics GmbHJHY2016-09-20
M5255516740Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255517650Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255520150SPIFE CK-20,40 Gel KitHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255520280SPIFE CK Reagent KitHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255523960QuickGel CK Vis Gel KitHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255525890Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07
M5255525900Blade Applicator Kit, 20 SampleHELENA LABORATORIES CORPORATIONJHY2016-09-07