COVID-19 test validation approved products
Find out which COVID-19 test products have been approved.
Documents
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.
Updates to this page
Last updated
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3 February 2025 Updated 'Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations'.
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23 December 2024 Updated Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations spreadsheet
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25 January 2024 COVID-19 test validation approved products spreadsheet updated.
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13 December 2023 Uploaded new Products approved under the Medical Device Coronavirus Test Device Approvals Amendment Regulations list as an excel spread sheet
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4 October 2023 The 'COVID-19 test validation approved products' file has been updated.
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4 September 2023 Published updated 'COVID-19 test validation approved products'
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22 August 2023 COVID-19 test validation approved products spreadsheet updated.
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15 August 2023 Published updated 'COVID-19 test validation approved products' data.
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24 July 2023 The correct spreadsheet of COVID-19 test validation approved products has been uploaded.
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6 July 2023 Updated 'COVID-19 test validation approved products' to July 2023.
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16 June 2023 Updated 'COVID-19 test validation approved products' file.
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9 June 2023 Updated 'COVID-19 test validation approved products' file.
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22 May 2023 Updated the register.
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19 May 2023 Updated the register.
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17 May 2023 Updated the register.
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15 May 2023 Updated the register.
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9 May 2023 Updated the register.
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26 April 2023 Updated the register.
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11 April 2023 Updated the register.
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30 March 2023 Updated the register.
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24 March 2023 Updated the register.
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9 March 2023 Updated the register.
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28 February 2023 Updated the register.
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27 February 2023 Updated the register.
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24 February 2023 Updated the register.
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9 February 2023 Updated the register.
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3 February 2023 Updated the register.
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2 February 2023 Updated the register.
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30 January 2023 Updated the register.
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16 January 2023 Updated the register.
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9 January 2023 Updated the register.
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3 January 2023 Updated the register.
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29 December 2022 Added link to statutory review of process for Coronavirus Test Device Approvals (CTDA)
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23 December 2022 Updated the register.
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12 December 2022 Updated the register.
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6 December 2022 Updated the register.
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5 December 2022 Updated the register.
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29 November 2022 Updated the register.
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17 November 2022 Updated the register.
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15 November 2022 Updated the register.
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9 November 2022 Updated the register.
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28 October 2022 Updated the register.
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25 October 2022 Updated the register.
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17 October 2022 Updated the register.
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3 October 2022 Updated the register.
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23 September 2022 Updated the register.
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15 September 2022 Updated the register.
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2 September 2022 Updated the register.
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1 September 2022 Updated to reflect the expiry of the protocols made under the Medical Devices Regulations 2002.
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19 August 2022 Removed SD Biosensor and Acon Biotech(Hangzhou) Co., Ltd products from protocol list and updated the register.
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18 August 2022 Updated the register.
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12 August 2022 Updated the register.
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3 August 2022 Updated the register.
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29 July 2022 Removed SD Biosensor, Inc. SARS-CoV-2 Antigen Self Test Nasal from the Self-test protocol - 6 months list.
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22 July 2022 Updated the register.
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21 July 2022 Updated 'COVID-19 test validation approved products' list.
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6 July 2022 Updated the register.
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24 June 2022 Updated the register.
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21 June 2022 Updated protocol page, changing Mediport Ltd to Beijing Beier Bioengineering Co Ltd.
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20 June 2022 Corrected CE Mark for MediPort Ltd in Self-test protocol.
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17 June 2022 Removed Anhui Deepblue Medical Technology Co device, updated certificate number for Zhejiang Orient Gene Biotech Co. device and updated the register.
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10 June 2022 Updated the register.
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7 June 2022 Updated 'COVID-19 test validation approved products' and removed 'Professional use protocol – 3 months'.
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30 May 2022 Updated the spreadsheet of approved products and List A: Professional Use Protocol.
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23 May 2022 Updated the register and removed one product from protocol list.
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17 May 2022 Added latest spreadsheet of approved products.
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16 May 2022 Removed 'Nanjing Liming Bio-Products Co Ltd - Strong Step SARS-CoV-2 Antigen Rapid Test' from the list.
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6 May 2022 Updated the register and removed 2 products from protocol list.
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28 April 2022 Updated the spreadsheet of approved products.
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26 April 2022 Updated the register and removed 2 products from protocol list.
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11 April 2022 Added latest spreadsheet of approved products.
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11 April 2022 Removed Becton Dickinson and Company from List A in Medical Devices Regulations.
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6 April 2022 Removed 2 Wuhan EasyDiagnosis antigen tests from protocol list: COVID-19 and Everything Genetic.
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30 March 2022 Amendments have been made to lines 11 and 28 on the approved products spreadsheet.
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21 March 2022 Updated spreadsheet to include manufacturer name on line 23.
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18 March 2022 Updated device name field for Zhejiang Orient Gene Biotech Co., Ltd.
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9 March 2022 Updated 'COVID-19 test validation approved products' and removed QuantuMDx Group from Protocol List A.
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7 March 2022 Updated spreadsheet and protocol list.
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3 March 2022 Updated spreadsheet.
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3 March 2022 Changed IFU number for Zhejiang Orient Gene Biotech Co.Ltd on the 6 month protocol list.
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1 March 2022 Removed old protocol.
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28 February 2022 Updated 'Medical Devices Regulations 2002: protocols (effective from 1 March 2022)'.
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24 February 2022 Added new protocol, effective from 1 March 2022.
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23 February 2022 Added Q-POC SARS-CoV-2 Assay (QuantuMDx Group Ltd) to the list of approved products.
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22 February 2022 Updated protocol list.
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17 February 2022 Further updated protocol list.
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17 February 2022 Updated CTDA register with new spreadsheet, removed 6 products and amended one product in the protocol list.
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20 January 2022 Removed Oxford Nanopore Diagnostics' LamPORE COVID-19 test kit from protocol list.
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20 January 2022 Updated COVID-19 test validation approved products.
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5 January 2022 Removed 'Roche Cobas SARS-COV-2 + Flu A + Flu B' from Protocol annexe list and added to approved devices.
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29 December 2021 Updated COVID-19 test validation approved products.
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20 December 2021 Updated 'COVID-19 test validation approved products'.
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15 December 2021 Removed Altona Diagnostics from Protocol annexe list.
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13 December 2021 Updated 'COVID-19 test validation approved products'.
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2 December 2021 Updated 'COVID-19 test validation approved products'.
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26 November 2021 Updated COVID-19 test validation approved products.
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25 November 2021 Updated spreadsheet with approved products added to the register.
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19 November 2021 Removed 2 products from Protocol annexe (Roche and Life Technologies Corporation) as they have now passed CTDA validation.
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15 November 2021 Removed Indicative performance category from spreadsheet.
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3 November 2021 Updated 'Medical Devices Regulations 2002: protocol'.
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29 October 2021 Updated COVID-19 test validation approved products.
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20 October 2021 Updated 'COVID-19 test validation approved products'.
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18 October 2021 First published.
Update history
2025-06-10 09:20
Changed to update Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations CSV file to most recent version.
2025-02-03 14:13
Updated ‘Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations’.
2024-12-23 13:52
Updated Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations spreadsheet
2024-01-25 15:12
COVID-19 test validation approved products spreadsheet updated.
2023-12-13 08:24
Uploaded new Products approved under the Medical Device Coronavirus Test Device Approvals Amendment Regulations list as an excel spread sheet
2023-10-04 14:26
The ‘COVID-19 test validation approved products’ file has been updated.
2023-09-04 10:43
Published updated ‘COVID-19 test validation approved products’
2023-08-22 09:32
COVID-19 test validation approved products spreadsheet updated.
2023-08-15 17:30
Published updated ‘COVID-19 test validation approved products’ data.
2023-07-24 15:44
The correct spreadsheet of COVID-19 test validation approved products has been uploaded.
2023-07-06 17:05
Updated ‘COVID-19 test validation approved products’ to July 2023.
2023-06-16 16:08
Updated ‘COVID-19 test validation approved products’ file.
2023-06-09 14:49
Updated ‘COVID-19 test validation approved products’ file.
2023-05-22 11:02
Updated the register.
2023-05-19 17:02
Updated the register.
2023-05-17 16:02
Updated the register.
2023-05-15 15:38
Updated the register.
2023-05-09 16:46
Updated the register.
2023-04-26 13:02
Updated the register.
2023-04-11 10:22
Updated the register.
2023-03-30 11:14
Updated the register.
2023-03-24 13:58
Updated the register.
2023-03-09 17:28
Updated the register.
2023-02-28 16:14
Updated the register.
2023-02-27 17:31
Updated the register.
2023-02-24 13:36
Updated the register.
2023-02-09 15:10
Updated the register.
2023-02-03 14:43
Updated the register.
2023-02-02 11:24
Updated the register.
2023-01-30 10:52
Updated the register.
2023-01-16 14:45
Updated the register.
2023-01-09 14:45
Updated the register.
2023-01-03 15:23
Updated the register.
2022-12-29 16:46
Added link to statutory review of process for Coronavirus Test Device Approvals (CTDA)
2022-12-23 11:57
Updated the register.
2022-12-12 14:01
Updated the register.
2022-12-06 15:56
Updated the register.
2022-12-05 13:12
Updated the register.
2022-11-29 10:35
Updated the register.
2022-11-17 14:46
Updated the register.
2022-11-15 12:45
Updated the register.
2022-11-09 11:10
Updated the register.
2022-10-28 16:14
Updated the register.
2022-10-25 11:45
Updated the register.
2022-10-17 09:30
Updated the register.
2022-10-03 11:50
Updated the register.
2022-09-23 11:39
Updated the register.
2022-09-15 10:36
Updated the register.
2022-09-02 10:49
Updated the register.
2022-09-01 09:30
Updated to reflect the expiry of the protocols made under the Medical Devices Regulations 2002.
2022-08-19 13:47
Removed SD Biosensor and Acon Biotech(Hangzhou) Co., Ltd products from protocol list and updated the register.
2022-08-18 11:16
Updated the register.
2022-08-12 11:42
Updated the register.
2022-08-03 09:53
Updated the register.
2022-07-29 11:53
Removed SD Biosensor, Inc. SARS-CoV-2 Antigen Self Test Nasal from the Self-test protocol – 6 months list.
2022-07-22 14:08
Updated the register.
2022-07-21 09:41
Updated ‘COVID-19 test validation approved products’ list.
2022-07-06 10:26
Updated the register.
2022-06-24 09:24
Updated the register.
2022-06-21 10:45
Updated protocol page, changing Mediport Ltd to Beijing Beier Bioengineering Co Ltd.
2022-06-20 11:02
Corrected CE Mark for MediPort Ltd in Self-test protocol.
2022-06-17 16:02
Removed Anhui Deepblue Medical Technology Co device, updated certificate number for Zhejiang Orient Gene Biotech Co. device and updated the register.
2022-06-10 10:46
Updated the register.
2022-06-07 09:59
Updated ‘COVID-19 test validation approved products’ and removed ‘Professional use protocol – 3 months’.
2022-05-30 13:44
Updated the spreadsheet of approved products and List A: Professional Use Protocol.
2022-05-23 09:57
Updated the register and removed one product from protocol list.
2022-05-17 09:46
Added latest spreadsheet of approved products.
2022-05-16 09:33
Removed ‘Nanjing Liming Bio-Products Co Ltd – Strong Step SARS-CoV-2 Antigen Rapid Test’ from the list.
2022-05-06 12:06
Updated the register and removed 2 products from protocol list.
2022-04-28 09:41
Updated the spreadsheet of approved products.
2022-04-26 09:58
Updated the register and removed 2 products from protocol list.
2022-04-11 15:26
Added latest spreadsheet of approved products.
2022-04-11 11:27
Removed Becton Dickinson and Company from List A in Medical Devices Regulations.
2022-04-06 11:16
Removed 2 Wuhan EasyDiagnosis antigen tests from protocol list: COVID-19 and Everything Genetic.
2022-03-30 17:37
Amendments have been made to lines 11 and 28 on the approved products spreadsheet.
2022-03-21 16:40
Updated spreadsheet to include manufacturer name on line 23.
2022-03-18 11:41
Updated device name field for Zhejiang Orient Gene Biotech Co., Ltd.
2022-03-09 16:26
Updated ‘COVID-19 test validation approved products’ and removed QuantuMDx Group from Protocol List A.
2022-03-07 15:29
Updated spreadsheet and protocol list.
2022-03-03 16:23
Updated spreadsheet.
2022-03-03 09:30
Changed IFU number for Zhejiang Orient Gene Biotech Co.Ltd on the 6 month protocol list.
2022-03-01 00:00
Removed old protocol.
2022-02-28 18:15
Updated ‘Medical Devices Regulations 2002: protocols (effective from 1 March 2022)’.
2022-02-24 14:00
Added new protocol, effective from 1 March 2022.
2022-02-23 10:44
Added Q-POC SARS-CoV-2 Assay (QuantuMDx Group Ltd) to the list of approved products.
2022-02-22 17:01
Updated protocol list.
2022-02-17 16:54
Further updated protocol list.
2022-02-17 14:49
Updated CTDA register with new spreadsheet, removed 6 products and amended one product in the protocol list.
2022-01-20 16:29
2022-01-20 10:28
2022-01-05 13:46
Removed ‘Roche Cobas SARS-COV-2 + Flu A + Flu B’ from Protocol annexe list and added to approved devices.
2021-12-29 11:34
Updated COVID-19 test validation approved products.
2021-12-20 15:31
Updated ‘COVID-19 test validation approved products’.
2021-12-15 12:57
Removed Altona Diagnostics from Protocol annexe list.
2021-12-02 16:34
Updated ‘COVID-19 test validation approved products’.
2021-11-26 16:42
Updated COVID-19 test validation approved products.
2021-11-25 15:18
Updated spreadsheet with approved products added to the register.
2021-11-19 16:22
Removed 2 products from Protocol annexe (Roche and Life Technologies Corporation) as they have now passed CTDA validation.
2021-11-15 10:54
Removed Indicative performance category from spreadsheet.
2021-11-03 13:07
Updated ‘Medical Devices Regulations 2002: protocol’.
2021-10-29 13:08
Updated COVID-19 test validation approved products.
2021-10-20 13:25
Updated 'COVID-19 test validation approved products'.
2021-10-18 19:24
First published.