8 result(s) found, displaying 1 to 8
- Cancellation by sponsorZenpharm Pty Ltd - Public N95 respirator Cancelled under Section 41GL(d) of the ActRequested by Zenpharm Pty Ltd
- Cancellation or suspensionCOVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)-ICOV421 (Cancelled from the ARTG under s.41GN(1)(b))Regulatory action due to The sponsor failed to fully comply with a request for information under s41JA and therefore failed to comply with a condition of inclusion under subsection 41FN(2) of the Act., effective 23/06/2020
- COVID-19 test kitCOVID-19 IgG/IgM Rapid Test CassetteLateral Flow IgG/IgM - Intended for use: Point-of-care test.
- Face mask market actionEndeavour KN95 Mask (Zenpharm Pty Ltd)Recall following review of quality, effectiveness and regulatory compliance.
- Face mask cancellationPublic respirator, single-use (Zenpharm Pty Ltd)Sponsor-initiated cancellation
- Face mask and respirator test reportEndeavour Surgical Face Mask (Zenpharm Pty Ltd)Laboratory testing results of Surgical Mask
- Face mask and respirator test reportEndeavour KN95 Mask (Zenpharm Pty Ltd)Laboratory testing results of Respirator