Home GUDID 10811877011245 WOUNDCHEK™ Bacterial Status
Primary DI 10811877011245
Brand WOUNDCHEK™ Bacterial Status
Company Alere Scarborough, Inc.
Model 360006US
Device description Intended for the assessment of bacterial protease activity in chronic wounds.
Published 2020-05-26
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name QFA Assay For Detection Of Proteases In Chronic Wounds
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QFA Assay For Detection Of Proteases In Chronic Wounds Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10811877011245 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10811877011245 10811877011245
GMDN Terms# Term, Definition table Term Definition Protease IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative measurement of protease 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.
Regulatory Flags# DUNS number 154148498 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company#