Home GUDID 00380740137007 Alinity
Primary DI 00380740137007
Brand Alinity
Company ABBOTT LABORATORIES
Model 07P8004
Catalog number 07P8004
Device description Alinity h-series Retic reagent
Published 2023-11-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GJH STAIN, RETICULOCYTE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GJH Stain, Reticulocyte Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00380740137007 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 00380740137007 00380740137007 380740137007 0380740137007
GMDN Terms# Term, Definition table Term Definition Reticulocyte count IVD, kit, cell count A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen using a manual, semi-automated or automated cell count method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 117245596 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number true 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# Other Devices Sharing Product Codes# 
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