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PRESAGE ST2 Controls Kit

Primary DI
00867556000171
Brand
PRESAGE ST2 Controls Kit
Company
CRITICAL CARE DIAGNOSTICS, INC.
Model
BC-1065x
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867556000171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867556000171008675560001718675560001710867556000171

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cardiac marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. The cardiac markers may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017390799
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867556000157EIA Test Kit BC-10662016-10-18
00867556000188EIA Test KitBC-10652016-10-18
00867556000195Presage ST2 Assay Kit BC-1066x2016-10-18