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MHRA, The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.

The Department of Health and Social Care (DHSC) has issued a policy paper about the scaling up of coronavirus (COVID-19) testing programmes.

The MHRA is working with partners to support the delivery of the government’s agenda on COVID-19 testing.

Following the outbreak of Covid-19 and the rapidly increasing need to provide urgent services and equipment, Genesis has get the MHRA certificate in May, 2021, right now it’s free to sale in UK market.
COVID-19
Genesis COVID-19 Antigen test kit (Professional use test)
A test which is intended to be used by a professional user (see below).
The test must be UKCA marked or CE marked as a “general IVD” in accordance with UK MDR 2002 (as amended).
The manufacturer of the test must demonstrate that they hold evidence to support the intended use as stated in their Instructions for use (IFU) e.g. If the manufacturer of a professional use COVID-19 test intends the test to be used in an assisted or supervised testing situation, then the IFU should make this clear and there should also be evidence of performance data to support their use in these situations.


Post time: Aug-16-2021