Notice Title

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
09445323077

PanBio COVID-19 Ag Rapid (Nasal)

Abbott Rapid Diagnostics Jena GmbH (Germany)

41FK11
41FK21
41FK51
41FK91
41FK71
41FK81

CareStart COVID-19 Antigen (Nasal)

Access Bio Inc (United States of America)

7006576 (20 pack)
7009998 (7 pack)
7006586 (20 pack)
7009997 (2 pack)
7006585 (1 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:

  1. 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.
  2. All NZ District Health Board hospitals.
  3. New Zealand Medical Assistance Team (NZMAT).
  4. New Zealand Police.
  5. Department of Corrections.
  6. New Zealand Defence Force.
  7. Parliamentary Service.
  8. All New Zealand-based businesses with a registered New Zealand Business Number (NZBN).
  9. The healthcare workforce including general practices and aged residential care.
  10. Government agencies.
  11. Non-Government agencies.
  12. Pharmacies.
  13. 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
09445323077

PanBio COVID-19 Ag Rapid (Nasal)

Abbott Rapid Diagnostics Jena GmbH (Germany)

41FK11
41FK21
41FK51
41FK91
41FK71
41FK81

CareStart COVID-19 Antigen (Nasal)

Access Bio Inc (United States of America)

7006576 (20 pack),
7009998 (7 pack),
7006586 (20 pack),
7009997 (2 pack),
7006585 (1 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.