Nano-Check Influenza+COVID-19 Dual Test

Basic Information

• Brand Name: Nano-Check Influenza+COVID-19 Dual Test
• Primary DI: 00895160002960
• Version / Model: MD8154
• Company Name: NANO-DITECH CORPORATION
• Labeler DUNS: 126544316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2026-01-16
• Public Version: 1
• Public Version Date: 2026-01-26
• Public Version Status: New
• Public Device Record Key: fa747c57-cb06-4dfb-b765-41de530c0db7

Device Description

The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions. Positive results do not rule out bacterial infection or co-infection with other viruses.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	866.3987	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64770	Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses and/or adenoviruses. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10895160002967	GS1
Primary	00895160002960	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius