COVID-19 test validation approved products
Find out which COVID-19 test products have been approved.
Documents
Update history
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.