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Guidance

COVID-19 test validation approved products

Find out which COVID-19 test products have been approved.

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
18 October 2021
Last updated:
18 September 2026
Show all updates

  1. Updated page to include the latest 'products approved' spreadsheet

  2. Update 'Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations'

  3. Updated spreadsheet containing Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations

  4. Updated 'Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations'

  5. Updated to add new version of Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations CSV spreadsheet

  6. Updated to add new version of Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations CSV file

  7. Updated page with latest attachment for Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations

  8. Updated 'Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations'

  9. Published update for 'Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations'.

  10. Updated 'Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations' CSV file.

  11. Changed to update Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations CSV file to most recent version.

  12. Updated 'Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations'.

  13. Updated Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations spreadsheet

  14. COVID-19 test validation approved products spreadsheet updated.

  15. Uploaded new Products approved under the Medical Device Coronavirus Test Device Approvals Amendment Regulations list as an excel spread sheet

  16. The 'COVID-19 test validation approved products' file has been updated.

  17. Published updated 'COVID-19 test validation approved products'

  18. COVID-19 test validation approved products spreadsheet updated.

  19. Published updated 'COVID-19 test validation approved products' data.

  20. The correct spreadsheet of COVID-19 test validation approved products has been uploaded.

  21. Updated 'COVID-19 test validation approved products' to July 2023.

  22. Updated 'COVID-19 test validation approved products' file.

  23. Updated 'COVID-19 test validation approved products' file.

  24. Updated the register.

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  43. Updated the register.

  44. Added link to statutory review of process for Coronavirus Test Device Approvals (CTDA)

  45. Updated the register.

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  56. Updated the register.

  57. Updated the register.

  58. Updated the register.

  59. Updated the register.

  60. Updated to reflect the expiry of the protocols made under the Medical Devices Regulations 2002.

  61. Removed SD Biosensor and Acon Biotech(Hangzhou) Co., Ltd products from protocol list and updated the register.

  62. Updated the register.

  63. Updated the register.

  64. Updated the register.

  65. Removed SD Biosensor, Inc. SARS-CoV-2 Antigen Self Test Nasal from the Self-test protocol - 6 months list.

  66. Updated the register.

  67. Updated 'COVID-19 test validation approved products' list.

  68. Updated the register.

  69. Updated the register.

  70. Updated protocol page, changing Mediport Ltd to Beijing Beier Bioengineering Co Ltd.

  71. Corrected CE Mark for MediPort Ltd in Self-test protocol.

  72. Removed Anhui Deepblue Medical Technology Co device, updated certificate number for Zhejiang Orient Gene Biotech Co. device and updated the register.

  73. Updated the register.

  74. Updated 'COVID-19 test validation approved products' and removed 'Professional use protocol – 3 months'.

  75. Updated the spreadsheet of approved products and List A: Professional Use Protocol.

  76. Updated the register and removed one product from protocol list.

  77. Added latest spreadsheet of approved products.

  78. Removed 'Nanjing Liming Bio-Products Co Ltd - Strong Step SARS-CoV-2 Antigen Rapid Test' from the list.

  79. Updated the register and removed 2 products from protocol list.

  80. Updated the spreadsheet of approved products.

  81. Updated the register and removed 2 products from protocol list.

  82. Added latest spreadsheet of approved products.

  83. Removed Becton Dickinson and Company from List A in Medical Devices Regulations.

  84. Removed 2 Wuhan EasyDiagnosis antigen tests from protocol list: COVID-19 and Everything Genetic.

  85. Amendments have been made to lines 11 and 28 on the approved products spreadsheet.

  86. Updated spreadsheet to include manufacturer name on line 23.

  87. Updated device name field for Zhejiang Orient Gene Biotech Co., Ltd.

  88. Updated 'COVID-19 test validation approved products' and removed QuantuMDx Group from Protocol List A.

  89. Updated spreadsheet and protocol list.

  90. Updated spreadsheet.

  91. Changed IFU number for Zhejiang Orient Gene Biotech Co.Ltd on the 6 month protocol list.

  92. Removed old protocol.

  93. Updated 'Medical Devices Regulations 2002: protocols (effective from 1 March 2022)'.

  94. Added new protocol, effective from 1 March 2022.

  95. Added Q-POC SARS-CoV-2 Assay (QuantuMDx Group Ltd) to the list of approved products.

  96. Updated protocol list.

  97. Further updated protocol list.

  98. Updated CTDA register with new spreadsheet, removed 6 products and amended one product in the protocol list.

  99. Removed Oxford Nanopore Diagnostics' LamPORE COVID-19 test kit from protocol list.

  100. Updated COVID-19 test validation approved products.

  101. Removed 'Roche Cobas SARS-COV-2 + Flu A + Flu B' from Protocol annexe list and added to approved devices.

  102. Updated COVID-19 test validation approved products.

  103. Updated 'COVID-19 test validation approved products'.

  104. Removed Altona Diagnostics from Protocol annexe list.

  105. Updated 'COVID-19 test validation approved products'.

  106. Updated 'COVID-19 test validation approved products'.

  107. Updated COVID-19 test validation approved products.

  108. Updated spreadsheet with approved products added to the register.

  109. Removed 2 products from Protocol annexe (Roche and Life Technologies Corporation) as they have now passed CTDA validation.

  110. Removed Indicative performance category from spreadsheet.

  111. Updated 'Medical Devices Regulations 2002: protocol'.

  112. Updated COVID-19 test validation approved products.

  113. Updated 'COVID-19 test validation approved products'.

  114. First published.

Documents

Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations

MS Excel Spreadsheet, 46.9 KB

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Details

Use the coronavirus (COVID-19) test validation approved products document to find out which products have been approved under Regulation 38A(5) of the Medical Devices Regulations 2002.

Read the COVID-19 test approval: how to apply guidance to find out more about the validation methodology and application process.

Read the policy review of the Coronavirus Test Device Approvals (CTDA) process, published in December 2022.

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