Home GUDID 17290018739089
MeMed BV® Calibrator
Primary DI 17290018739089
Brand MeMed BV® Calibrator
Company MEMED DIAGNOSTICS LTD
Model FG31001
Published 2023-07-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name QPS Immunoassay For Host Biomarkers Of Infection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QPS Immunoassay For Host Biomarkers Of Infection Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17290018739089 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 17290018739089 17290018739089
GMDN Terms# Term, Definition table Term Definition Multiple cell-mediated host immune response marker IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or (semi-)quantitative detection of multiple cell-mediated (i.e., non-immunoglobulin) host immune response markers of bacterial and/or viral infection in a clinical specimen. It is typically used to aid in the differentiation of bacterial and viral infection, and/or to predict patient outcomes by grading disease severity.
Regulatory Flags# DUNS number 533243445 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 17290018739072 Performance Verification Kit for MeMed Tests Based On TRAIL/ IP-10/ CRP FG00004 2022-09-22 17290018739010 MeMed BV® FG10001 2021-12-06 17290018739003 MeMed Key® FG130001 2021-10-26 17290018739027 MeMed BV® Calibrator FG11001 2021-10-26 17290018739034 MeMed BV® External Control FG12001 2021-10-26
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