Guidance

COVID-19 test validation approved products

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

From:
UK Health Security Agency
Published
18 October 2021
Last updated
616 May 2022 — See all updates

Documents

COVID-19 test validation approved products

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Medical Devices Regulations 2002: protocols

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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.

The Medical Devices Regulations 2002 Protocol, published under regulation 39A(2), permits certain COVID-19 test devices to remain on the market without approval. The protocol sets out the conditions of this permission and the annexes list the COVID-19 test devices that it applies to.

The protocol has been issued to address the serious public health risk any potential shortage of supply may cause. Supply of tests listed in the protocol annexes must cease within 10 working days if the test fails validation.

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

Published 18 October 2021
Last updated 616 May 2022 + show all updates

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

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

  3. Updated the spreadsheet of approved products.

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

  5. Added latest spreadsheet of approved products.

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

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

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

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

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

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

  12. Updated spreadsheet and protocol list.

  13. Updated spreadsheet.

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

  15. Removed old protocol.

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

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

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

  19. Updated protocol list.

  20. Further updated protocol list.

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

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

  23. Updated COVID-19 test validation approved products.

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

  25. Updated COVID-19 test validation approved products.

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

  27. Removed Altona Diagnostics from Protocol annexe list.

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

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

  30. Updated COVID-19 test validation approved products.

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

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

  33. Removed Indicative performance category from spreadsheet.

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

  35. Updated COVID-19 test validation approved products.

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

  37. First published.