Nano-Check Influenza+COVID-19 Dual Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243561 FDA 510(k)
- FDA Product Code
- SCA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3987 FDA 510(k)
- Regulation Number
- 866.3987 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nano-Check Influenza+COVID-19 Dual Test is a Multi-Analyte Respiratory Virus Antigen Detection Test, designed to simultaneously identify influenza A, influenza B, and SARS-CoV-2 antigens in anterior nasal swab (ANS) specimens. It functions as a rapid immunoassay to detect nucleoprotein antigens specific to influenza strains and nucleocapsid antigens associated with COVID-19, aiding in the differential diagnosis of respiratory infections.
This device is intended for CLIA-waived/point-of-care testing and delivers results within 15 minutes. Supplied as a single-use diagnostic kit, it requires no specialized equipment beyond standard laboratory or clinical settings. The test is regulated under FDA 510(k) clearance (K243561) and CLIA waiver (CW240029), ensuring compliance with in vitro diagnostic use guidelines. Storage and handling follow standard protocols for immunoassay devices.
Frequently asked questions
What types of respiratory infections can the Nano-Check Influenza+COVID-19 Dual Test detect simultaneously?
The Nano-Check Influenza+COVID-19 Dual Test is designed to simultaneously detect influenza A, influenza B, and SARS-CoV-2 (the virus responsible for COVID-19) antigens in anterior nasal swab specimens. This allows for rapid differentiation between these common respiratory infections in a single test.
Is this test suitable for use in a point-of-care or CLIA-waived setting, and how quickly can results be obtained?
Yes, the Nano-Check Influenza+COVID-19 Dual Test is intended for CLIA-waived/point-of-care testing, meaning it can be used in settings like clinics, physician offices, or urgent care without needing a full clinical laboratory. Results are delivered within 15 minutes, making it ideal for quick diagnostic decisions.
How is the Nano-Check Influenza+COVID-19 Dual Test supplied, and is it reusable?
The Nano-Check Influenza+COVID-19 Dual Test is supplied as a single-use diagnostic kit, meaning each test is intended for one use only. This ensures sterility and accuracy per the manufacturer’s design, eliminating the need for reprocessing or reuse.
What regulatory clearances or approvals does this test hold, and how does that affect its use?
The Nano-Check Influenza+COVID-19 Dual Test holds FDA 510(k) clearance (K243561) and a CLIA waiver (CW240029), confirming it meets U.S. regulatory standards for in vitro diagnostic use. The CLIA waiver specifically allows it to be used in non-laboratory settings (e.g., point-of-care) without requiring high-complexity testing protocols.
What type of specimen is required for the Nano-Check Influenza+COVID-19 Dual Test, and does it require specialized equipment?
The test requires an anterior nasal swab (ANS) specimen collected from the patient. No specialized equipment is needed beyond standard laboratory or clinical setting tools, such as those used for routine immunoassays. The test is designed for simplicity in point-of-care environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Nano-CheckTM Influenza+COVID-19 Dual Test - Nano-Ditech Corporation, PDF Nano-Check™ Influenza+COVID-19 Dual Te, Nano-Check Influenza+COVID-19 Dual Test - Healthcare Provider Fact Sheet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243561 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nano-Ditech Corporation
Sources (1)
- FDA 510(k) K243561 24 fields · synced Sep 18, 2026