Nano-CheckTM Malaria

Primary DI
00895160002465
Brand
Nano-CheckTM Malaria
Company
NANO-DITECH CORPORATION
Model
MD8142
Catalog number
MD8142
Device description
An in vitro diagnostic test for the detection of malaria HRP2 (histidine-rich protein 2) of Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) of Plasmodium vivax in human whole blood as an aid in the diagnosis of malaria infection.
Published
2017-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAXPlasmodium Spp. Detection Reagents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAXPlasmodium Spp. Detection ReagentsMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00895160002465PrimaryGS10
10895160002462Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00895160002465008951600024658951600024650895160002465
1089516000246210895160002462

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Plasmodium species antigen IVD, kit, immunochromatographic test (ICT), rapidA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-297-7877info@nanoditech.com
1-609-409-3300info@nanoditech.com

Regulatory Flags#

DUNS number
126544316
Device count
20
Kit
true
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 DIBrandModelCatalogPublished
00895160002427Fluoro-CheckTM PCTTF3161TF31612016-10-05
00895160002878Nano-Check™ Influenza A+B TestMD81532026-01-22
10895160002875Nano-Check™ Influenza A+B TestMD81532026-01-22
00895160002960Nano-Check Influenza+COVID-19 Dual TestMD81542026-01-16
10895160002967Nano-Check Influenza+COVID-19 Dual TestMD81542026-01-16
00895160002847Nano-Check Influenza+COVID-19 Dual TestMD8151E2024-08-08
10895160002844Nano-Check Influenza+COVID-19 Dual TestMD8151E2024-08-08
00895160002854Nano-Check RSV TestMD81522024-08-08
00895160002861Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147 2T2024-04-01
10895160002868Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147 2T2024-04-01
00895160002786Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147-20T2020-11-18
00895160002243Nano-Check™ OPI TestAD41832023-06-27
10895160002240Nano-Check™ OPI TestAD41832023-06-27
00895160002663Nano-CheckTM COVID-19 IgG/IgM Antibody TestMD81452020-04-10
00895160002670Fluoro-CheckTM CRP Test TF31632020-09-22
00895160002687Nano-Check TM Strep A TestMD81482022-03-15
00895160002694Nano-Check TM CRP plus TestCD71572022-03-15
00895160002724Nano-Check TM COVID-19 IgG Antibody TestMD81462020-09-22
00895160002793Fluoro-Check TM COVID-19 Antigen TestTF-81502020-11-25
00895160002120Nano-CheckTM AMI 2 in 1CD202PCD202P2016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733102165Alethia Malaria External Control KitMERIDIAN BIOSCIENCE, INC.OAX2020-10-26
00840733102240Alethia MalariaMERIDIAN BIOSCIENCE, INC.OAX2020-10-26
00840733102257Alethia Malaria PLUSMERIDIAN BIOSCIENCE, INC.OAX2020-10-26
05391516746724Bio-RadCLARK LABORATORIES, INC.OAX2019-11-07
05391516746731Bio-RadCLARK LABORATORIES, INC.OAX2019-11-07
05391516745123Trinity BiotechCLARK LABORATORIES, INC.OAX2016-09-22
05391516745130Trinity BiotechCLARK LABORATORIES, INC.OAX2016-09-22
05391516745147Trinity BiotechCLARK LABORATORIES, INC.OAX2016-09-19
10811877010361BinaxNOW® MalariaAlere Scarborough, Inc.OAX2016-09-03
10811877010378BinaxNOW® MalariaAlere Scarborough, Inc.OAX2016-09-03