Guidance

COVID-19 test validation approved products

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 October 2021
• Last updated: 25 January 2024 — See all updates

Documents

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

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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.

Published 18 October 2021
Last updated 25 January 2024 + show all updates

1. 25 January 2024

   COVID-19 test validation approved products spreadsheet updated.

2. 13 December 2023

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

3. 4 October 2023

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

4. 4 September 2023

   Published updated 'COVID-19 test validation approved products'

5. 22 August 2023

   COVID-19 test validation approved products spreadsheet updated.

6. 15 August 2023

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

7. 24 July 2023

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

8. 6 July 2023

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

9. 16 June 2023

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

10. 9 June 2023

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

11. 22 May 2023

    Updated the register.

12. 19 May 2023

    Updated the register.

13. 17 May 2023

    Updated the register.

14. 15 May 2023

    Updated the register.

15. 9 May 2023

    Updated the register.

16. 26 April 2023

    Updated the register.

17. 11 April 2023

    Updated the register.

18. 30 March 2023

    Updated the register.

19. 24 March 2023

    Updated the register.

20. 9 March 2023

    Updated the register.

21. 28 February 2023

    Updated the register.

22. 27 February 2023

    Updated the register.

23. 24 February 2023

    Updated the register.

24. 9 February 2023

    Updated the register.

25. 3 February 2023

    Updated the register.

26. 2 February 2023

    Updated the register.

27. 30 January 2023

    Updated the register.

28. 16 January 2023

    Updated the register.

29. 9 January 2023

    Updated the register.

30. 3 January 2023

    Updated the register.

31. 29 December 2022

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

32. 23 December 2022

    Updated the register.

33. 12 December 2022

    Updated the register.

34. 6 December 2022

    Updated the register.

35. 5 December 2022

    Updated the register.

36. 29 November 2022

    Updated the register.

37. 17 November 2022

    Updated the register.

38. 15 November 2022

    Updated the register.

39. 9 November 2022

    Updated the register.

40. 28 October 2022

    Updated the register.

41. 25 October 2022

    Updated the register.

42. 17 October 2022

    Updated the register.

43. 3 October 2022

    Updated the register.

44. 23 September 2022

    Updated the register.

45. 15 September 2022

    Updated the register.

46. 2 September 2022

    Updated the register.

47. 1 September 2022

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

48. 19 August 2022

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

49. 18 August 2022

    Updated the register.

50. 12 August 2022

    Updated the register.

51. 3 August 2022

    Updated the register.

52. 29 July 2022

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

53. 22 July 2022

    Updated the register.

54. 21 July 2022

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

55. 6 July 2022

    Updated the register.

56. 24 June 2022

    Updated the register.

57. 21 June 2022

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

58. 20 June 2022

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

59. 17 June 2022

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

60. 10 June 2022

    Updated the register.

61. 7 June 2022

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

62. 30 May 2022

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

63. 23 May 2022

    Updated the register and removed one product from protocol list.

64. 17 May 2022

    Added latest spreadsheet of approved products.

65. 16 May 2022

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

66. 6 May 2022

    Updated the register and removed 2 products from protocol list.

67. 28 April 2022

    Updated the spreadsheet of approved products.

68. 26 April 2022

    Updated the register and removed 2 products from protocol list.

69. 11 April 2022

    Added latest spreadsheet of approved products.

70. 11 April 2022

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

71. 6 April 2022

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

72. 30 March 2022

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

73. 21 March 2022

    Updated spreadsheet to include manufacturer name on line 23.

74. 18 March 2022

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

75. 9 March 2022

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

76. 7 March 2022

    Updated spreadsheet and protocol list.

77. 3 March 2022

    Updated spreadsheet.

78. 3 March 2022

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

79. 1 March 2022

    Removed old protocol.

80. 28 February 2022

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

81. 24 February 2022

    Added new protocol, effective from 1 March 2022.

82. 23 February 2022

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

83. 22 February 2022

    Updated protocol list.

84. 17 February 2022

    Further updated protocol list.

85. 17 February 2022

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

86. 20 January 2022

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

87. 20 January 2022

    Updated COVID-19 test validation approved products.

88. 5 January 2022

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

89. 29 December 2021

    Updated COVID-19 test validation approved products.

90. 20 December 2021

    Updated 'COVID-19 test validation approved products'.

91. 15 December 2021

    Removed Altona Diagnostics from Protocol annexe list.

92. 13 December 2021

    Updated 'COVID-19 test validation approved products'.

93. 2 December 2021

    Updated 'COVID-19 test validation approved products'.

94. 26 November 2021

    Updated COVID-19 test validation approved products.

95. 25 November 2021

    Updated spreadsheet with approved products added to the register.

96. 19 November 2021

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

97. 15 November 2021

    Removed Indicative performance category from spreadsheet.

98. 3 November 2021

    Updated 'Medical Devices Regulations 2002: protocol'.

99. 29 October 2021

    Updated COVID-19 test validation approved products.

100. 20 October 2021

     Updated 'COVID-19 test validation approved products'.

101. 18 October 2021

     First published.