Home GUDID 00840937110126 Immunalysis Corporation
Primary DI 00840937110126
Brand Immunalysis Corporation
Company IMMUNALYSIS CORPORATION
Model 218-0480EX
Device description Immunalysis Corporation Fentanyl Direct ELISA Export Kit: 5 Plate 218-0480EX
Published 2017-05-15
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 00840937110126 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 00840937110126 00840937110126 840937110126 0840937110126
GMDN Terms# Term, Definition table Term Definition Amphetamine-specific IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of a specific amphetamine in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 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#