Home GUDID 00840937110966 Immunalysis Corporation
Primary DI 00840937110966
Brand Immunalysis Corporation
Company IMMUNALYSIS CORPORATION
Model 3016-5
Device description Immunalysis Corporation Oxycodone Oral Fluid Control Set
Published 2018-06-22
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 00840937110966 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 00840937110966 00840937110966 840937110966 0840937110966
GMDN Terms# Term, Definition table Term Definition Oxycodone IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of oxycodone 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#