FDA.reportPublic FDA data

PATHFAST CK-MB-II

Primary DI
04987595301339
Brand
PATHFAST CK-MB-II
Company
PHC CORPORATION
Model
N/A
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081360000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081360000PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku Iatron2009-08-17JHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987595301339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987595301339049875953013394987595301339

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassayA 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 a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
716055632
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987595300011PATHFAST Sample Diluent 1N/A2025-04-18
04987595300028PATHFAST Sample Diluent 2N/A2025-04-18
04987595300646PATHFASTN/A3006462023-06-12
04987595301131PATHFAST cTnI-IIN/A2016-09-22
04987595301230PATHFAST Myo-IIN/A2016-09-22
04987595301537PATHFAST D-DimerN/A2016-09-22
04987595301636PATHFAST NTproBNPN/A2016-09-22
04987595301742PATHFAST hsCRPN/A2016-09-22
04987595301803PATHFAST hs-cTnI-IIN/A3018032024-05-01
04987905300236PHCbiMCO-170MG-PA2018-04-25
04987905300199PHCbiMDF-U334-PA2018-04-25
04987905300205PHCbiMDF-U5312-PA2018-04-25
04987905300212PHCbiMCO-5M-PA2018-04-25
04987905300045PanasonicMCO-170AICUV-PA2016-09-24
04987905300069PanasonicMCO-19M-PA2016-09-24
04987905300076PanasonicMCO-19MUV-PA2016-09-24
04987905300090PanasonicMCO-230AICUV-PA2016-09-24
04987905300113PanasonicMCO-5M-PA2016-09-24
04987905300120PanasonicMCO-170M-PA2016-09-24
04987905300229PHCbiMCO-170M-PA2018-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590781521Access CK-MBBeckman Coulter, Inc.JHX2024-03-01
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