Point of Care Archives

Flowflex SARS-CoV-2 Antigen Rapid Test Receives Health Canada Approval

Posted on 15 February 2022

Flowflex SARS-CoV-2 Antigen Rapid Tests have gained Health Canada sales & import authorisation for lab-based and point of care testing. The Health Canada has assessed the relative sensitivity & specicificity, and accurancy of each approved test, with Flowflew performing as follows: Relative Sensitivity: 97.1% Relative Specificity: 99.5% Accuracy: 98.8% The tests are authorised for the […]

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— Primera Healthcare

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— Pay Broadbent

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— Jackson Handling

Hygiene UK is great business providing essential supplies to essential services.

— Hope City Foundation

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— Global Office Supplies

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— Seldram Supplies

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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.

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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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Avatar Hygiene UK @HygieneUK1·

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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