COVID-19/FluA/FluB Antigen Detection Kit(Colloidal Gold)

Primary DI

16972235840038

Basic UDI-DI Code

B-16972235840038

Reference

LCV07

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhuhai Lituo Biotechnology Co., Ltd.

The COVID-19/FluA/FluB Antigen Detection Kit is a lateral flow immunoassay intended for the qualitative detection of SARSCoV- 2, influenza A and influenza B viral nucleoprotein antigens in nasopharyngeal swab from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. The COVID-19/FluA/FluB Antigen Detection Kit is intended for the detection and differentiation of SARS-CoV-2, influenza A and influenza B viral nucleoprotein antigens. Antigens are generally detectable in nasopharyngeal specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. Negative results do not rule out SARS-CoV-2, influenza A or influenza B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results must be combined with clinical observations, patient history and epidemiological information, and confirmed with a molecular assay, if necessary for patient management. The COVID-19/FluA/FluB Antigen Detection Kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).