Nano-Check Influenza+COVID-19 Dual Test

GUDID 10895160002844

The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The Nano-Check™ Influenza+COVID-19 Dual Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved.

NANO-DITECH CORPORATION

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
Primary Device ID10895160002844
NIH Device Record Keyf18c3d34-9ad5-4935-b28a-7afb37a80f9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano-Check Influenza+COVID-19 Dual Test
Version Model NumberMD8151E
Company DUNS126544316
Company NameNANO-DITECH CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone609-409-3300
Emailinfo@nanoditech.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002847 [Primary]
GS110895160002844 [Unit of Use]

FDA Product Code

QKPCoronavirus Antigen Detection Test System.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-16
Device Publish Date2024-08-08

Devices Manufactured by NANO-DITECH CORPORATION

10895160002844 - Nano-Check Influenza+COVID-19 Dual Test2024-08-16The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The Nano-Check™ Influenza+COVID-19 Dual Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been cleared or approved.
10895160002844 - Nano-Check Influenza+COVID-19 Dual Test2024-08-16 The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simult
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10895160002868 - Nano-Check TM COVID-19 Antigen Test2024-04-09 An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
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