Nano-CheckTM Malaria MD8142

GUDID 00895160002465

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.

NANO-DITECH CORPORATION

Multiple Plasmodium species antigen IVD, kit, immunochromatographic test (ICT), rapid Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical
Primary Device ID00895160002465
NIH Device Record Keyf5953fe3-1650-49b3-a125-8fa1d574a780
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano-CheckTM Malaria
Version Model NumberMD8142
Catalog NumberMD8142
Company DUNS126544316
Company NameNANO-DITECH CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone855-297-7877
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002465 [Primary]
GS110895160002462 [Unit of Use]

FDA Product Code

OAXPlasmodium Spp. Detection Reagents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-07
Device Publish Date2017-05-04

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