INSTANT-VIEW Troponin I Whole Blood/Serum Test (Cassette)

Primary DI
10796918001808
Brand
INSTANT-VIEW Troponin I Whole Blood/Serum Test (Cassette)
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
05-8575
Device description
INSTANT-VIEW Troponin I Whole Blood/Serum Test (Cassette)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MMIImmunoassay Method, Troponin Subunit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10796918001808PrimaryGS10
00796918001801Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800180810796918001808
00796918001801007969180018017969180018010796918001801

GMDN Terms#

Term, Definition table
TermDefinition
Troponin I IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176391167
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

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