FDA.report

AIA-PACK CK-MB Calibrator Set

Primary DI
04560189211674
Brand
AIA-PACK CK-MB Calibrator Set
Company
TOSOH CORPORATION
Model
N/A
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JHXFluorometric Method, Cpk Or Isoenzymes

Product Code Classifications

CodeDeviceSpecialtyClass
JHXFluorometric Method, Cpk Or IsoenzymesClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560189211674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560189211674045601892116744560189211674

GMDN Terms

TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
614-317-1909Levent.durukan@tosoh.com
650-615-8134Dave.Wurtz@tosoh.com

Regulatory Flags

DUNS number
690571724
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DIBrandCompanyProduct codePublished
15099590781521Access CK-MBBeckman Coulter, Inc.JHX2024-03-01
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00380740174941AlinityAbbott Ireland DiagnosticsJHX2019-11-11
00380740174927AlinityAbbott Ireland DiagnosticsJHX2019-06-07
30014613337164TriageQUIDEL 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
14560189210728ST AIA-PACK CK-MBTOSOH CORPORATIONJHX2016-09-24
04560189211681AIA-PACK CK-MB Sample Diluting SolutionTOSOH CORPORATIONJHX2016-09-24
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00842768004445Stratus® CS STAT Fluorometric Analyzer CannulaSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004469Stratus® CS Acute Care™ CCRP TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
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00842768004537Stratus® CS Acute Care™ cTNI CalPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
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00842768024863Stratus® CSSiemens Healthcare Diagnostics Inc.JHX2016-09-24
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03573026161613VIDAS® CK-MBBIOMERIEUX SAJHX2016-08-31
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