Abbott Rapid Diagnostics Panbio™ COVID-19 Antigen Self-Test

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Class:

Class D IVD

Manufactured by:

Abbott Rapid Diagnostics Jena GmbH

Therapeutic area:

Immunology

Therapeutic indications:

The Panbio™ COVID-19 Antigen Self-Test is a single-use, in vitro (outside the body) visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen (Ag). The Panbio™ COVID-19 Antigen Self-Test is intended to be used manually by untrained lay users (self testing) in a private setting to aid in the diagnosis of an active SARS-CoV-2 infection. Children under 14 years should be supported by an adult.

Product summary:

Models: Panbio™ COVID-19 Antigen Self-Test - 41FK51, Panbio™ COVID-19 Antigen Self-Test - 41FK91, Panbio™ COVID-19 Antigen Self-Test - 41FK71, Panbio™ COVID-19 Antigen Self-Test - 41FK81

Authorization date:

2023-06-14