Home GUDID 00380740137021
Alinity
Primary DI 00380740137021
Brand Alinity
Company Abbott Ireland Diagnostics
Model 07P7904
Catalog number 07P7904
Device description Alinity h-series WBC 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
Product Codes# Code, Name table Code Name GGJ FLUID, DILUTING, WHITE-CELL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GGJ Fluid, Diluting, White-Cell Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00380740137021 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 00380740137021 00380740137021 380740137021 0380740137021
GMDN Terms# Term, Definition table Term Definition White blood cell 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 the white blood cell (leukocyte) count and/or the differential of white cell types 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 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 985307301 Device count 1 Premarket exempt true Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00192024092304 Ricca Chemical Company® Ricca Chemical Company, LLC GGJ 2021-02-04 00192024092311 Ricca Chemical Company® Ricca Chemical Company, LLC GGJ 2021-02-04 00192024092328 Ricca Chemical Company® Ricca Chemical Company, LLC GGJ 2021-02-04