FDA.reportPublic FDA data

Access CK-MB

Primary DI
15099590781521
Brand
Access CK-MB
Company
Beckman Coulter, Inc.
Model
D00534
Catalog number
D00534
Device description
The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Published
2024-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JHXFluorometric Method, Cpk Or Isoenzymes

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590781521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959078152115099590781521

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) 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 qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) 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
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
10758750034314VITROSORTHO CLINICAL DIAGNOSTICSJHX2022-10-24
00380740174941AlinityAbbott Ireland DiagnosticsJHX2019-11-11
00380740174927AlinityAbbott Ireland DiagnosticsJHX2019-06-07
30014613337157TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337164TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337928TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337942TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337966TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
00845275002348Thermo Scientific Fisher DiagnosticsJHX2017-06-22
14858218671006Test2 Release 1.6.3Booz Allen Hamilton Inc.JHX2017-05-05
14858218671008Test2 Release 1.6.3Booz Allen Hamilton Inc.JHX2017-05-05
14858218671009Test2 Release 1.6.3Booz Allen Hamilton Inc.JHX2017-05-05
00893038002807Alere Triage®Alere San Diego, Inc.JHX2016-09-26
00899722002719Alere Triage®Alere San Diego, Inc.JHX2016-09-26
00899722002740Alere Triage®Alere San Diego, Inc.JHX2016-09-26
00899722002795Alere Triage®Alere San Diego, Inc.JHX2016-09-26
14560189210728ST AIA-PACK CK-MBTOSOH CORPORATIONJHX2016-09-24
04560189211674AIA-PACK CK-MB Calibrator SetTOSOH CORPORATIONJHX2016-09-24
04560189211681AIA-PACK CK-MB Sample Diluting SolutionTOSOH CORPORATIONJHX2016-09-24
00842768004438Stratus® CS STAT Fluorometric Analyzer CannulaSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004445Stratus® CS STAT Fluorometric Analyzer CannulaSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004469Stratus® CS Acute Care™ CCRP TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004476Stratus CS Acute Care CCRP CalPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004490Stratus® CS Acute Care™ CKMB TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004506Stratus® CS Acute Care™ CKMB CalPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004513Stratus® CS Acute Care™ CKMB DilPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004520Stratus® CS Acute Care™ cTNI TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004537Stratus® CS Acute Care™ cTNI CalPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004544Stratus® CS Acute Care™ cTNI DilPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24