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Departmental
Notice Title

Notice of Expansion to Authorisation of Persons to Import, Supply and Distribute Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021

Publication Date
25 Jan 2022

Tags

Health COVID-19 Testing Places COVID-19 Public Health Response (Point-of-care Tests) Order 2021

Notice Number

2022-go235
Title
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File Type and Size
PDF (26 KB)

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:

  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 organisations.
  12. Pharmacies.
  13. Local Authorities, Departments, and Government.

to import, supply, distribute, sell to other authorised persons or classes of persons, and use (excluding the importation or supply for any individual’s personal use) the following point-of-care tests:

Product Name Manufacturer Configuration
SARS-CoV-2 Rapid Antigen Test (SD Biosensor) (Nasal, Nasopharyngeal, or Oropharyngeal swab) SD Biosensor (South Korea) Professional or self-test of any package size
PanBio COVID-19 Ag Rapid (Nasal, Nasopharyngeal, or Oropharyngeal swab) Abbott Rapid Diagnostics Jena GmbH (Germany) Professional or self-test of any package size
CareStart COVID-19 Antigen (Nasal, Nasopharyngeal, or Oropharyngeal swab) Access Bio Inc (United States of America) Professional or self-test of any package size
CLINITEST® Rapid COVID-19 Antigen Test (Nasal, Nasopharyngeal, or Oropharyngeal swab) Healgen Scientific Limited Liability Company (United States of America) Professional or self-test of any package size
Orient Gene Rapid COVID-19 (Antigen) Test (Nasal, Nasopharyngeal, or Oropharyngeal swab) Zhejiang Orient Gene Biotech Co., Ltd (China) Professional or self-test of any package size
Atomo COVID-19 Antigen Test (Nasal, Nasopharyngeal, or Oropharyngeal swab) Access Bio Inc (United States of America) Professional or self-test of any package size

BD Veritor System for Rapid Detection of SARS-CoV-2 (Nasal swab)

BD kit for rapid detection of SARS-CoV-2 (Nasal swab, visually read)

 Becton, Dickinson and Company (United States of America) Professional or self-test of any package size
Sofia SARS Antigen FIA Test kit with Sofia and Sofia 2 analyser (Nasal swab) Quidel Corporation (United States of America) and Puritan Medical Products Company LLC (United States of America) Professional or self-test of any package size
Ecotest COVID-19 Antigen Nasal Test Kit (Nasal swab) Assure Tech (Hangzhou) Co Ltd (China) Professional or self-test of any package size


Dated at Wellington this 24th day of January 2022.

Dr ASHLEY BLOOMFIELD, Director-General of Health, Ministry of Health.