Home GUDID 20816490020039 Healgen
Primary DI 20816490020039
Brand Healgen
Company Healgen Scientific Limited Liability Company
Model HURS-11T
Catalog number HURS-11T
Device description 11 parameter Urine Strip
Published 2017-05-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10816490020032 Package GS1 100 In Commercial Distribution 20816490020039 Package GS1 100 In Commercial Distribution 00816490020035 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10816490020032 10816490020032 20816490020039 20816490020039 00816490020035 00816490020035 816490020035 0816490020035
GMDN Terms# Term, Definition table Term Definition Multiple urine analyte IVD, kit, colorimetric dipstick, rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 031802328 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company#