AllTest COVID-19 Antigen Rapid Test (Oral fluid) (ICOV-802) and (ICOV802H) Self Test, JusChek COVID-19 Antigen Rapid Test (Oral fluid) (ICOV-802) and (ICOV802H) Self Test, and Beright COVID-19 Antigen Rapid Test (Oral fluid) (ICOV-802) and (ICOV-802H) Self Test |
Oral Fluid (saliva) |
Professional or self-test of any package size |
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (PDF, 22 KB) |
Rapid SARS-CoV-2 Antigen Test Card
MP Biomedicals Asia Pacific Pte Ltd. (Singapore)
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Nasal, nasopharyngeal and oropharyngeal swab
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Professional use of any package size
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (PDF)
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Roche SARS-CoV-2 Rapid Antigen Test (SD Biosensor)
SD Biosensor (Republic of Korea)
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Nasal, nasopharyngeal swab
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Professional or self-test of any package size
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
PanBio COVID-19 Ag Rapid
Abbott Rapid Diagnostics Jena GmbH (Germany)
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Nasal, nasopharyngeal swab
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Professional or self-test of any package size
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
CareStart COVID-19 Antigen
CareStart COVID-19 home test
Access Bio Inc (United States of America)
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Nasal, nasopharyngeal swab |
Professional or self-test of any package size
|
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
Atomo COVID-19 Antigen Test
Access Bio Inc (United States of America)
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Nasal, nasopharyngeal swab |
Professional or self-test of any package size
|
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
CLINITEST Rapid COVID-19 Antigen Test
Healgen Scientific Limited Liability Company (United States of America) or Zhejiang Orient Gene Biotech Co., Ltd (China)
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Nasal, nasopharyngeal swab |
Professional or self-test of any package size
|
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
Healgen Rapid COVID-19 Antigen Test and Orient Gene Rapid COVID-19 Antigen Test
Healgen Scientific Limited Liability Company (United States of America) or Zhejiang Orient Gene Biotech Co., Ltd (China)
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Nasal, nasopharyngeal swab |
Professional or self-test of any package size
|
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
BD Veritor System for Rapid Detection of SARS-CoV-2 and BD kit for rapid detection of SARS-CoV-2 (visually read)
Becton, Dickinson and Company (United States of America)
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Nasal swab
|
Professional or self-test of any package size
|
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
Sofia SARS Antigen FIA Test kit with Sofia and Sofia 2 analyser
Quidel Corporation (United States of America) or Puritan Medical Products Company LLC (United States of America)
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Nasal swab
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Professional or self-test of any package size
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
Ecotest COVID-19 Antigen Nasal Test Kit
Assure Tech (Hangzhou) Co Ltd (China)
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Nasal swab or nasal pen
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Professional or self-test of any package size
Please note the Ecotest SARS-CoV2 test is not recommended for use in children under the age of 2 years
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
STANDARD Q COVID-19 Ag Test
STANDARD i-Q COVID-19 Ag Home Test
SD Biosensor (Republic of Korea)
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Nasal, nasopharyngeal swab |
Professional or self-test of any package size
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
GenBody COVID-19 Ag Test
GenBody Inc. (Republic of Korea)
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Nasal, nasopharyngeal swab |
Professional or self-test of any package size
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 24 February 2022 (PDF) |
BIOCREDIT COVID-19 Ag Home Test
RapiGEN Inc. (Republic of Korea)
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Nasal |
Professional or self-test of any package size |
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Expansion to Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 15 March 2022 (PDF) |
FlowFlex SARS-CoV-2 Antigen Rapid Test
ACON Biotech (Hangzhou) Co., Ltd. (China)
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Nasal
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Professional or self-test of any package size
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Expansion to Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 31 March 2022 (PDF) |
Zybio SARS-CoV-2 Antigen Assay Kit
Zybio Inc. (China)
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Nasal swab
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Self-test of any package size
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- Zybio SARS-CoV-2 Antigen Assay Kit instructions for use
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 22 April 2022 (PDF) |
StrongStep SARS-CoV-2 Antigen Rapid Test
Nanjing Liming Bio-Products Co., Ltd (China)
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Nasal swab |
Professional or self-test of any package size |
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 28 April 2022 (PDF)
Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 28 April 2022 (PDF)
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CLUNGENE COVID-19 Antigen Rapid Test
Hangzhou Clongene Biotech Co., Ltd (China)
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Nasal swab |
Self-test of any package size |
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 28 April 2022 (PDF)
Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 28 April 2022 (PDF)
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INDICAID COVID-19 Rapid Antigen Test
PHASE Scientific International, Ltd. (Hong Kong and United States of America)
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Nasal swab |
Professional or self-test of any package size |
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 28 April 2022 (PDF)
Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 28 April 2022 (PDF)
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SARS-CoV-2 Antigen Kit (Colloidal Gold)
Goldsite Diagnostics, Inc. (China)
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Nasal swab |
Self-test of any package size |
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 20 - 26 May 2022 (PDF) |
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Nasal swab |
Self-test |
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 22 August 2022 (PDF) |
AllTest SARS-CoV-2 Antigen Rapid Test
Hangzhou Alltest Biotech Co Ltd, (China)
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Nasal swab
|
Professional or self-test of any package size |
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 8 September 2022 (PDF)
Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 8 September 2022 (PDF)
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JusChek SARS-CoV-2 Antigen Rapid Test
Hangzhou AllTest Biotech Co., Ltd. (China)
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Nasal swab
|
Professional or self-test of any package size |
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 8 September 2022 (PDF)
Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 8 September 2022 (PDF)
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BeRight SARS-CoV-2 Antigen Rapid Test
Hangzhou AllTest Biotech Co., Ltd. (China)
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Nasal Swab
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Professional or self-test of any package size |
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 8 September 2022 (PDF)
Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 8 September 2022 (PDF)
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Gold Standard Diagnostics (GSD) SARS-CoV-2 Antigen Rapid Test
Hangzhou AllTest Biotech Co., Ltd. (China)
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Nasal swab
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Self-test of any package size
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 8 September 2022 (PDF)
Corrigendum—Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 8 September 2022 (PDF)
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LumiraDx SARS-CoV-2 Ag Test
LumiraDx UK Ltd (United Kingdom)
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Nasal, nasopharyngeal swab |
Professional use only of any package size |
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Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 - 21 December 2022 (PDF) |