Home GUDID 00840937110782 Immunalysis Corporation
Primary DI 00840937110782
Brand Immunalysis Corporation
Company IMMUNALYSIS CORPORATION
Model QS-0025-DPEX
Device description Immunalysis Corporation Quantisal 0025 (Dual Pad) Export
Published 2018-03-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840937110782 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 00840937110782 00840937110782 840937110782 0840937110782
GMDN Terms# Term, Definition table Term Definition Drug-testing specimen collection kit IVD A covered receptacle and other associated materials/tools, available either [non-prescription] over-the-counter and/or to health professionals, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other investigation. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 18 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 080589004 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#