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Nano-Check Influenza+COVID-19 Dual Test

NANO-DITECH CORPORATION · Model MD8154 · UDI-DI 00895160002960

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510(k) clearances

Adverse events

Recalls

Facilities

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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.