SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SG Diagnostics

Class:

Class D IVD

Manufactured by:

SG Diagnostics Pte Ltd

Therapeutic area:

Immunology

Therapeutic indications:

The SG Diagnostics COVID-19 Antigen Rapid Test Kit is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is intended for use with nasal, nasopharyngeal or throat swab samples in individuals who are suspected of COVID-19. This test utilizes a lateral flow immunoassay technology for the qualitative detection of spike and nucleocapsid protein antigens of SARS-CoV-2 in individuals with known or suspected COVID-19. Results are for the identification of SARS-CoV-2 spike and nucleocapsid protein antigens. Antigens are generally detectable in swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with individual's clinical history and other diagnostic information is necessary to determine infection status. The SG Diagnostics COVID-19 Antigen Rapid Test Kit is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests.

Product summary:

Models: SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) - SG0010A, SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) - SG0010B

Authorization date:

2022-01-12