Home GUDID 05060242472916
Ortho™ BioClone™ PLUS Anti-M (Murine Monoclonal) (IgG)
Primary DI 05060242472916
Brand Ortho™ BioClone™ PLUS Anti-M (Murine Monoclonal) (IgG)
Company ALBA BIOSCIENCE LIMITED
Model 6141126
Device description This Anti-M reagent is for the in vitro detection and identification of the human M blood group antigen by direct agglutination.
Published 2026-07-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05060242472619 Package GS1 1 In Commercial Distribution 05060242472916 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060242472619 05060242472619 5060242472619 05060242472916 05060242472916 5060242472916
GMDN Terms# Term, Definition table Term Definition Anti-M red blood cell grouping IVD, antibody One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for M [MNS001] red blood cell antigens from the MNS system, using an agglutination method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 516536641 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false 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 true No natural rubber latex false Sterilization required before use false Other Devices From This Company#