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 ID: 10895160002844
• NIH Device Record Key: f18c3d34-9ad5-4935-b28a-7afb37a80f9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nano-Check Influenza+COVID-19 Dual Test
• Version Model Number: MD8151E
• Company DUNS: 126544316
• Company Name: NANO-DITECH CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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
• 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
• 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
• 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	00895160002847 [Primary]
GS1	10895160002844 [Unit of Use]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

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: 2024-08-16
• Device Publish Date: 2024-08-08

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