ONSITE DIAGNOSTICS PTY LTD - Severe acute respiratory syndrome-associated coronavirus IVDs (334505)

ARTG ID 334505

ARTG Name

ONSITE DIAGNOSTICS PTY LTD - Severe acute respiratory syndrome-associated coronavirus IVDs

Product name

Severe acute respiratory syndrome-associated coronavirus IVDs

ARTG Date

17 April 2020

Registration Type

Device

Therapeutic good type

MD

Manufacturers

Zhejiang Orient Gene Biotech Co Ltd

Licence category

IVD

Licence status

A

Licence class

Class 3

Summary

14 April 2020

COVID-19 test kit

COVID-19 IgG/IgM Rapid Test Cassette

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

ONSITE DIAGNOSTICS PTY LTD - Severe acute respiratory syndrome-associated coronavirus IVDs (2019-20)

Exempt from annual charge in 2019-20 due to ONSITE DIAGNOSTICS PTY LTD declaring $0 turnover in that period.