Revocation and Replacement—Authorisations and Exemptions of Point of Care Tests
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:
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.