A revocation and replacement to this notice was published on 2 December 2021, Notice No. 2021-go5180.

Notice Type
Departmental
Notice Title

Appendix 1 – Notice for Phase 1 of Point-of-Care Testing Programme

Pursuant to clause 8 of the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (“Order”), I, as the Director-General of Health, hereby specify the following persons or class of persons to import, supply and sell point-of-care tests for COVID-19 for the purposes of clause 8 of the Order:

Name of Company New Zealand Business Number
Roche Diagnostics NZ Ltd 9429039820518
Abbott Rapid Diagnostics 9429032718850
Pantonic Health (Australia) or Arrotex Pharmaceuticals (NZ) Limited 9429041542033
EBOS Group Ltd 94290319988404
Ministry of Health 9429000082440


Pursuant to clause 8 of the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (“Order”), I, as the Director-General of Health, hereby specify the following persons or class of persons to use point-of-care tests for COVID-19 for the purposes of clause 8 of the Order:

  1. All laboratories accredited by International Accreditation New Zealand (IANZ) to ISO 15189 for COVID-19 testing, and providing laboratory testing services to District Health Boards.
  2. All NZ District Health Board hospitals.
  3. New Zealand Medical Assistance Team (NZMAT).
  4. All signatory businesses to the Ministry of Business, Innovation and Employment Business Charter.
  5. New Zealand Police.
  6. Department of Corrections.

Pursuant to clause 9 of the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (“Order”), I, as the Director-General of Health, hereby specify the following point-of-care tests or class of point-of-care tests that are exempt from clause 7(b) of the Order:

Product Name Manufacturer Product Code
SARS-CoV-2 Rapid Antigen Test (SD Biosensor) (Nasal) SD Biosensor (South Korea) 09365397043
PanBio COVID-19 Ag Rapid (Nasal) Abbott Rapid Diagnostics Jena GmbH (Germany) 41FK11
CareStart COVID-19 Antigen (Nasal) Access Bio Inc (United States of America) 7006576


Dated this 10th day of November 2021.

Dr ASHLEY BLOOMFIELD, Director-General of Health.