ALLSAFE MEDICAL PTY LTD - Severe acute respiratory syndrome-associated coronavirus IVDs (334542)

ARTG ID 334542

ARTG Name

ALLSAFE MEDICAL PTY LTD - Severe acute respiratory syndrome-associated coronavirus IVDs

Product name

Severe acute respiratory syndrome-associated coronavirus IVDs

ARTG Date

18 April 2020

Registration Type

Device

Therapeutic good type

MD

Manufacturers

Guangzhou Wondfo Biotech Co Ltd

Licence category

IVD

Licence status

A

Licence class

Class 3

Summary

Annual charge exemption

ALLSAFE MEDICAL PTY LTD - Severe acute respiratory syndrome-associated coronavirus IVDs (2019-20)

Exempt from annual charge in 2019-20 due to ALLSAFE MEDICAL PTY LTD declaring $0 turnover in that period.
17 April 2020

COVID-19 test kit

SARS-CoV-2 Antibody Test (Lateral Flow Method)

Lateral Flow IgG/IgM - Intended for use: Point-of-care test.