Home GUDID 07340035504443 HLA-B*58
Primary DI 07340035504443
Brand HLA-B*58
Company CareDx AB
Model 101.568-06u
Published 2023-07-18
Public version status New
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 07340035504443 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07340035504443 07340035504443 7340035504443
GMDN Terms# Term, Definition table Term Definition HLA class I antigen tissue typing IVD, kit, multiplex A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I antigens in a clinical specimen, using a multiplex method.
Regulatory Flags# DUNS number 558836388 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 true 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#