Home GUDID 20816490021050 Healgen
Primary DI 20816490021050
Brand Healgen
Company Healgen Scientific Limited Liability Company
Model GALH-103b
Catalog number GALH-103b
Device description LH Ovulation Rapid Test Midstream(Urine,40mIU/mL)
Published 2016-12-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Sterile false
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10816490021053 Package GS1 20 In Commercial Distribution 20816490021050 Package GS1 50 In Commercial Distribution 00816490021056 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 10816490021053 10816490021053 20816490021050 20816490021050 00816490021056 00816490021056 816490021056 0816490021056
GMDN Terms# Term, Definition table Term Definition Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) 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.
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# 
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