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: 104 ~~June~~August 2025 — See all updates

Documents

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

~~CSV~~MS Excel Spreadsheet, ~~55.9~~44.4 KB

~~View~~ ~~online~~

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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 104 ~~June~~August 2025 + show all updates

4 August 2025
Published update for 'Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations'.

30 July 2025
Updated 'Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations' CSV file.

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

COVID-19 test validation approved products

Documents

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

Details

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