FDA.reportPublic FDA data

Presage ST2 Assay Kit

Primary DI
00867556000195
Brand
Presage ST2 Assay Kit
Company
CRITICAL CARE DIAGNOSTICS, INC.
Model
BC-1066x
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867556000195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867556000195008675560001958675560001950867556000195

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using an enzyme immunoassay (EIA) method. Cardiac markers to be assayed 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

Contacts#

Phone, Email table
PhoneEmail
877-700-1250orders@criticaldiagnostics.com

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
00867556000171PRESAGE ST2 Controls KitBC-1065x2016-10-18
00867556000188EIA Test KitBC-10652016-10-18