Nano-Check Influenza+COVID-19 Dual Test

GUDID 10895160002967

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.

NANO-DITECH CORPORATION

Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 10895160002967
• NIH Device Record Key: fa747c57-cb06-4dfb-b765-41de530c0db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nano-Check Influenza+COVID-19 Dual Test
• Version Model Number: MD8154
• Company DUNS: 126544316
• Company Name: NANO-DITECH CORPORATION
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00895160002960 [Primary]
GS1	10895160002967 [Unit of Use]

FDA Product Code

• SCA: Multi-Analyte Respiratory Virus Antigen Detection Test

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-26
• Device Publish Date: 2026-01-16

On-Brand Devices [Nano-Check Influenza+COVID-19 Dual Test]

• 10895160002844: The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay int
• 10895160002967: The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay int