-
SARS-CoV-2 Antigen Rapid Test Device (Saliva)
INTENDED USE The SARS-CoV-2 Antigen Rapid Test device is a rapid visual immunoassay for the qualitative, presumptive detection of SARS-CoV-2 antigens form Nasal swabs specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute SARS-CoV-2 virus infection. PRINCIPLE The detection of SARS-COV-2 adopts the principle of double antibody sandwich method and colloidal gold immunochromatography to qualitatively detect SARS-COV-2 antigen in human Nasopharyng... -
SARS-CoV-2 Antigen Rapid Test Device(Self-Testing)
The SARS-CoV-2 Antigen Rapid Test device is a rapid visual immunoassay for the qualitative, presumptive detection of SARS-CoV-2 antigens form Nasal swabs specimens. A nasal swab sample can be self-collected by an individual aged 15-70 years. People between the ages of 15 and 70 who are unable to collect samples by themselves may be assisted by other adults. The test is intended for self-testing use as an aid in the rapid differential diagnosis of acute SARS-CoV-2 virus infection.
-
SARS-COV-2/Influenza A+B Antigen Combo Rapid Test Device
The Influenza A+B/COVID-19 Antigen Rapid Test Device is a rapid visual immunoassay for the qualitative, presumptive detection of influenza A and B viral antigens and COVID-19 Antigen form throat swabs and nasopharyngeal swab specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B virus and COVID-19 infection.
-
COVID-19 IgG/IgM Rapid Test Device
INTENDED USE The COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–COVID-19 virus and IgM anti-COVID-19 virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with COVID-19 viruses. Any reactive specimen with the COVID-19 IgG/IgM Rapid Test must be confirmed with alternative testing method(s). PRINCIPLE The COVID-19 IgG/IgM... -
COVID-19 Ag Rapid Test Device
The SARS-COV-2 Antigen Rapid Test Device is a rapid visual immunoassay for the qualitative, presumptive detection of COVID-19 antigens form throat swabs and nasopharyngeal swab specimens.
It is intended to be used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with novel Coronavirus.
Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this test.
-
SARS-CoV-2 Neutralizing Antibody Rapid Test Device
The SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of the presence of neutralizing antibodies to SARS-CoV-2.
