Infectious disease IVDs

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Prieinama:

Synalinx Pty Ltd

Klasė:

Class 1

Pagaminta:

Strumed Solutions Private Limited 1st Floor Module No 06 - BTCIF TICEL Bio Park - Phase II CSIR Road, Taramani, Chennai, 600113 India

Gydymo sritis:

CT701 - Infectious disease IVDs

Terapinės indikacijos:

The kit is a rapid chromatographic immunoassay for the qualitative detection of antigens specific to SARS-CoV-2 in nasal/nasopharyngeal swabs containing samples collected from a human nasopharynx. This product provides only a preliminary test result. The test is recommended for administration by qualified healthcare workers as an aid for rapid differential diagnosis of SARS-CoV-2 infection in patients with associated clinical symptoms.

Autorizacija statusas:

A

Leidimo data:

2022-01-17