TGA Approval Archives

Flowflex SARS-CoV-2 Antigen Rapid Test Receives TGA Approval In Australia

Posted on 30 January 2022

Flowflex SARS-CoV-2 Antigen Rapid Test has been authorised for as a self-test by the Australian Government Department of Heath Therapeutic Goods Administration (TGA). The TGA’s performance requirements for COVID-19 rapid antigen self-tests are internationally aligned with technical specifications published by the World Health Organisation (WHO), and the European Commission. This includes a clinical sensitivity of […]

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We first ordered products from Hygiene UK at the start of the pandemic as our usual suppliers could not supply, and had increased their prices drastically. We were offered competitively priced and good quality PPE at a time when not many suppliers could. You delivered timely deliveries to all of my locations, and your team are always friendly and helpful. I will continue to work with you when required.

— Primera Healthcare

We've used Hygiene UK many times and have nothing but good things to say. Great Prices, reliable & quick delivery. We use Hygiene UK to supply our blue-chip clients so confidence is a must! Thoroughly recommend!

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A vast range of PPE products at competitive prices, but crucially the expertise behind the products and the quality of them is second to none.

— Pay Broadbent

A great company to deal with, extremely reliable with a good range of products. Excellent product knowledge, great communication & customer service, fair prices and fast delivery.

— Jackson Handling

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

— Hope City Foundation

Huge range of products at great prices. At a time of desperate need many were taking advantage of people, but not Hygiene UK. They have helped us and have been nothing but perfect. If you’re looking for masks, gloves, aprons, etc please give the team at Hygiene UK a call!

— Global Office Supplies

Pleasure to deal with, great communication and overall service levels. Highly recommended.

— 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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