COVID Test Archives - Hygiene UK

Flowflex and Healgen Lateral Flow Rapid Antigen Tests – FAQs

Posted on 29 July 2021

What is a Lateral Flow Rapid Antigen Test? A SARS-COV-2 lateral flow antigen rapid test is used to quickly process samples on-site without the need for laboratory equipment, generating results in minutes. This kind of rapid diagnostic test is suitable for point-of-care and self-testing (dependant on brand), that directly detects the presence or absence of […]

ACON’s Flowflex test receives CE mark for self-testing

Posted on 18 May 2021

ACON, one of the professional in-vitro diagnostic products manufacturers, has announced that its Flowflex SARS-CoV-2 Antigen Rapid Test has been CE marked for self-testing throughout the European Union. The CE certificate is issued by TUV SUD (CE0123) and validated from 14th May 2021 until 26th May 2024. SARS-CoV-2 Antigen tests play a critical role in the fight […]

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— Seldram Supplies

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FAQs

Find what you might need in our FAQ's...

What is an IVD medical device?

An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body.

What does in vitro diagnostic use mean?

In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass', meaning these tests are typically conducted in test tubes, cassettes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

What is In Vitro Diagnostic Regulation (IVDR)?

The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.

When was the IVDR Implemented?

The IVDR came into force on 25 May 2017. Several implementing acts/guidance documents are being issued by the EU commission and are stipulated to complete some of the requirements to be met.

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6 Jan 2021

Hygiene UK COVID19 Testing kits launched and available in the UK.
https://hygiene-uk.com/news/hygiene-uk-announces-the-launch-of-their-flowflex-antigen-covid-19-test/

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