Home GUDID 10888234002406 Panoscreen EXTEND
Primary DI 10888234002406
Brand Panoscreen EXTEND
Company IMMUCOR, INC.
Model 0002383
Device description Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
Published 2019-10-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name QHT Reagent Red Blood Cells
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QHT Reagent Red Blood Cells Hematology U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10888234002406 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10888234002406 10888234002406
GMDN Terms# Term, Definition table Term Definition Antibody identification panel reagent red blood cell IVD, kit, agglutination A collection of four or more specifically characterized reagent red blood cells that are supplied together as a set and intended to be used to determine the exact specificity of antibodies to red blood cell antigens present in a clinical specimen, using an agglutination method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 1 Degrees Celsius 10 Degrees Celsius
Regulatory Flags# DUNS number 061446282 Device count 1 Kit true Lot or batch 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 10888234001522 Referencells IMMUCOR, INC. QHT 2022-08-03 10888234001539 Capture-R Ready-Screen 3 IMMUCOR, INC. QHT 2022-08-01