Home GUDID 00840733102165 Alethia Malaria External Control Kit
Primary DI 00840733102165
Brand Alethia Malaria External Control Kit
Company MERIDIAN BIOSCIENCE, INC.
Model 479970
Catalog number 479970
Device description The Alethia Malaria External Control Kit contains Positive and Negative Control Reagents for use with the Alethia Malaria or Alethia Malaria PLUS DNA Amplification Assays. External controls are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors.
Published 2020-10-26
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 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 00840733102165 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 00840733102165 00840733102165 840733102165 0840733102165
GMDN Terms# Term, Definition table Term Definition Multiple Plasmodium species nucleic acid IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple species of Plasmodium (malaria parasites) in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 092815364 Device count 1 Premarket exempt true 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 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 10811877010378 BinaxNOW® Malaria Alere Scarborough, Inc. OAX 2016-09-03
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