Home GUDID 10811877010378 BinaxNOW® Malaria
Primary DI 10811877010378
Brand BinaxNOW® Malaria
Company Alere Scarborough, Inc.
Model 665-025
Device description For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.
Published 2016-09-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name OAX Plasmodium Spp. Detection Reagents
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OAX Plasmodium Spp. Detection Reagents Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10811877010378 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10811877010378 10811877010378
GMDN Terms# Term, Definition table Term Definition Multiple Plasmodium species antigen IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple species of Plasmodium, the malaria parasites (e.g., P. falciparum, P. vivax, P. ovale, P. knowlesi, P. malariae), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
Regulatory Flags# DUNS number 154148498 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 00840733102165 Alethia Malaria External Control Kit MERIDIAN BIOSCIENCE, INC. OAX 2020-10-26 00840733102240 Alethia Malaria MERIDIAN BIOSCIENCE, INC. OAX 2020-10-26 00840733102257 Alethia Malaria PLUS MERIDIAN BIOSCIENCE, INC. OAX 2020-10-26 05391516746724 Bio-Rad CLARK LABORATORIES, INC. OAX 2019-11-07 05391516746731 Bio-Rad CLARK LABORATORIES, INC. OAX 2019-11-07 00895160002465 Nano-CheckTM Malaria NANO-DITECH CORPORATION OAX 2017-05-04 05391516745123 Trinity Biotech CLARK LABORATORIES, INC. OAX 2016-09-22 05391516745130 Trinity Biotech CLARK LABORATORIES, INC. OAX 2016-09-22 05391516745147 Trinity Biotech CLARK LABORATORIES, INC. OAX 2016-09-19 10811877010361 BinaxNOW® Malaria Alere Scarborough, Inc. OAX 2016-09-03