SARS-CoV-2 Antigen Rapid Qualitative Test Type B

The BiotimeTSH/FT3/FT4Rapid Quantitative Test is intended to quantitatively detect the concentration of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) in human serum and plasma samples on the Biotime FIA Analyzer by fluorescent immunoassay. The test is used as an adjunctive diagnosis of thyroid function. For in vitro diagnostic use only. For professional use only.

The MPV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of IgM and IgG antibodies to Monkeypox Virus (MPV) in human serum, plasma, venous whole blood, or fingertip blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to MPV, indicating recent or prior infection. At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The MPV IgG/IgM Rapid Test should not be used to diagnose acute MPV infection. For professional in vitro diagnostic use only.

The ADV Antigen Rapid Test is a rapid lateral flow immunoassay for the qualitative detection of adenovirus antigen (ADV) directly from nasal/throat/nasopharyngeal swabs. It is intended to be used by professionals as a screening test and to provide preliminary test results to help diagnose acute Adenovirus infection. It provides only an initial screening test result. For professional in vitro diagnostic use only.

The Dengue Ag&Ab Combo Rapid Test is a rapid membrane based chromatographic immunoassay for for the qualitative detection of NS1 antigen and IgM/IgG antibodies to all four serotypes (DEN-1, DEN-2, DEN-3 and DEN-4) of Dengue virus in human serum, plasma or whole blood. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of primary and secondary Dengue infection. For professional in vitro diagnostic use only.

The Biotime hscTnI (highly sensitive cardiac troponin I) Rapid Quantitative Test is intended to quantify the concentration of cTnI in human serum, plasma, or whole blood on Biotime FIA Analyzers(Semi-automatic / Automatic) by fluorescent immunoassay. It is used as an aid in the detection of myocardial Infarction. -Fluorescent immunoassay -Myocardial Infarction For in vitro diagnostic use only. For professional use only.

The Dengue IgG/IgM Rapid Test is a rapid membrane based chromatographic immunoassay for qualitative and differential detection of IgG and IgM antibodies to all four serotypes (DEN-1, DEN-2, DEN- 3 and DEN-4) of Dengue virus in human serum, plasma or whole blood. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of primary and secondary Dengue infection. For professional in vitro diagnostic use only.