Home GUDID 00840937107522 Immunalysis Corporation
Primary DI 00840937107522
Brand Immunalysis Corporation
Company IMMUNALYSIS CORPORATION
Model CH-126-750
Device description Immunalysis Corporation Moss TMBHK (High Kinetics TMB) (750 mL)
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 00840937107522 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 00840937107522 00840937107522 840937107522 0840937107522
GMDN Terms# Term, Definition table Term Definition Chromogenic substrate reagent IVD A reagent or solution that gives off colour in a biochemical reaction, intended to be used in combination with other IVDs in the testing of a clinical specimen, typically using an enzyme immunoassay method.
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#