Home GUDID 00840937101889 Immunalysis Corporation
Primary DI 00840937101889
Brand Immunalysis Corporation
Company IMMUNALYSIS CORPORATION
Model 311-0500
Device description Immunalysis Corporation Methamphetamine Oral Fluids HEIA Kit 500
Published 2016-08-31
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 00840937101889 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 00840937101889 00840937101889 840937101889 0840937101889
GMDN Terms# Term, Definition table Term Definition Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of a specific methamphetamine in a clinical specimen, using an enzyme immunoassay (EIA) method.
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#