Pursuant to clause 8 of the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (“Order”), I, the Director-General of Health, hereby authorise the following persons or class of persons to do any or all of the activities prohibited by clause 7 of the Order.
The authorised persons or class of persons are:
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 |
9429031998840 |
Ministry of Health |
9429000082440 |
Siemens Healthcare Ltd (trading as Siemens Healthineers) |
9429041698822 |
The above persons or classes of persons are authorised to import, supply and sell the following point-of-care tests:
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 (20 pack) |
CLINITEST® Rapid COVID-19 Antigen Test |
Healthgen Scientific Limited Liability Company (United States of America) |
11555845 |
Pursuant to clause 8 of the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (“Order”), I, the Director-General of Health, hereby authorise the following persons or class of persons to use point-of-care tests to test for SARS-CoV-2 or COVID-19:
The persons or class of persons authorised to use point-of-care tests are:
- All laboratories accredited by International Accreditation New Zealand (IANZ) to ISO 15189 for COVID-19 testing and who provides laboratory testing services to District Health Boards.
- All NZ District Health Board hospitals.
- New Zealand Medical Assistance Team (NZMAT).
- New Zealand Police.
- Department of Corrections.
- New Zealand Defence Force.
- Parliamentary Service.
- All New Zealand-based businesses with a registered New Zealand Business Number (NZBN).
- The healthcare workforce including general practices and aged residential care.
- Government agencies.
- Non-Government agencies.
- Pharmacies.
- Local Authorities, Departments, and Government.
The above authorised persons or classes of persons (1–13) are authorised to supply, distribute, and sell to other authorised persons or classes of persons (1–13), and use the following point-of-care tests:
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 (20 pack), |
CLINITEST® Rapid COVID-19 Antigen Test |
Healthgen Scientific Limited Liability Company (United States of America) |
11555845 |
Dated this 15th day of December 2021.
Dr ASHLEY BLOOMFIELD, Director-General of Health.
* This notice revokes and replaces “Revocation and Replacement—Notice of Point of Care Test Order Authorisations*” published in the New Zealand Gazette, 2 December 2021, Notice No. 2021-go5180; “Appendix 1 – Notice for Phase 1 of Point-of-Care Testing Programme” published in the New Zealand Gazette, 11 November 2021, Notice No. 2021-go4887 and “Notice for Point of Care Testing Authorisation” published in the New Zealand Gazette, 25 November 2021, Notice No. 2021-go5095.