CK-MB Test

Primary DI
00657498000748
Brand
CK-MB Test
Company
STANBIO LABORATORY, L.P.
Model
0980-103
Catalog number
0980-103
Device description
For the Quantitative Determination of Creatine Kinase-MB (CK-MB) in Serum for Manual and/or Automated Procedures.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHWU.V. Method, Cpk Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHWU.V. Method, Cpk IsoenzymesClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00657498000748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498000748006574980007486574980007480657498000748

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
1
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817274021293JAS DiagnosticsDREW SCIENTIFIC, INC.JHW2016-09-09
00817274021309JAS DiagnosticsDREW SCIENTIFIC, INC.JHW2016-09-09
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00811727010940POINTE SCIENTIFIC CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2016-08-31
00811727010957POINTE SCIENTIFIC CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2016-08-31
00811727010964POINTE SCIENTIFIC CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2016-08-31