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.
Last updated
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Updated the register.
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Updated to reflect the expiry of the protocols made under the Medical Devices Regulations 2002.
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Removed SD Biosensor and Acon Biotech(Hangzhou) Co., Ltd products from protocol list and updated the register.
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Updated the register.
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Updated the register.
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Updated the register.
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Removed SD Biosensor, Inc. SARS-CoV-2 Antigen Self Test Nasal from the Self-test protocol - 6 months list.
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Updated the register.
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Updated 'COVID-19 test validation approved products' list.
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Updated the register.
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Updated the register.
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Updated protocol page, changing Mediport Ltd to Beijing Beier Bioengineering Co Ltd.
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Corrected CE Mark for MediPort Ltd in Self-test protocol.
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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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Updated the register.
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Updated 'COVID-19 test validation approved products' and removed 'Professional use protocol – 3 months'.
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Updated the spreadsheet of approved products and List A: Professional Use Protocol.
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Updated the register and removed one product from protocol list.
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Added latest spreadsheet of approved products.
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Removed 'Nanjing Liming Bio-Products Co Ltd - Strong Step SARS-CoV-2 Antigen Rapid Test' from the list.
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Updated the register and removed 2 products from protocol list.
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Updated the spreadsheet of approved products.
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Updated the register and removed 2 products from protocol list.
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Added latest spreadsheet of approved products.
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Removed Becton Dickinson and Company from List A in Medical Devices Regulations.
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Removed 2 Wuhan EasyDiagnosis antigen tests from protocol list: COVID-19 and Everything Genetic.
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Amendments have been made to lines 11 and 28 on the approved products spreadsheet.
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Updated spreadsheet to include manufacturer name on line 23.
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Updated device name field for Zhejiang Orient Gene Biotech Co., Ltd.
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Updated 'COVID-19 test validation approved products' and removed QuantuMDx Group from Protocol List A.
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Updated spreadsheet and protocol list.
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Updated spreadsheet.
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Changed IFU number for Zhejiang Orient Gene Biotech Co.Ltd on the 6 month protocol list.
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Removed old protocol.
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Updated 'Medical Devices Regulations 2002: protocols (effective from 1 March 2022)'.
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Added new protocol, effective from 1 March 2022.
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Added Q-POC SARS-CoV-2 Assay (QuantuMDx Group Ltd) to the list of approved products.
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Updated protocol list.
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Further updated protocol list.
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Updated CTDA register with new spreadsheet, removed 6 products and amended one product in the protocol list.
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Removed Oxford Nanopore Diagnostics' LamPORE COVID-19 test kit from protocol list.
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Updated COVID-19 test validation approved products.
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Removed 'Roche Cobas SARS-COV-2 + Flu A + Flu B' from Protocol annexe list and added to approved devices.
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Updated COVID-19 test validation approved products.
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Updated 'COVID-19 test validation approved products'.
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Removed Altona Diagnostics from Protocol annexe list.
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Updated 'COVID-19 test validation approved products'.
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Updated 'COVID-19 test validation approved products'.
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Updated COVID-19 test validation approved products.
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Updated spreadsheet with approved products added to the register.
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Removed 2 products from Protocol annexe (Roche and Life Technologies Corporation) as they have now passed CTDA validation.
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Removed Indicative performance category from spreadsheet.
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Updated 'Medical Devices Regulations 2002: protocol'.
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Updated COVID-19 test validation approved products.
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Updated 'COVID-19 test validation approved products'.
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First published.