Innova Medical Group, a health screening and diagnostic innovator, manufacturer, and distributor of lateral flow test kits, has earned CE mark certification for its Innova SARS-CoV-2 Antigen Rapid Qualitative Self-Test.
The European CE mark Conformity Assessment reviewed Innova’s clinical support and performance data and evaluated the strength and effectiveness of its Quality Management Systems (QMS).
Innova's rapid antigen self-test has been widely used, studied, tested, scrutinised, and analysed, and has been approved for distribution in markets around the world including United Kingdom, Israel, Malaysia, Sultanate of Oman, Qatar and now the 27 countries of the EU.
The company is furthering its mission by applying for authorisation and certifications in countries where rapid antigen self-tests are needed most.
Robert Kasprzak, CEO of Innova Medical Group, said: "Since the COVID-19 pandemic outbreak in March 2020, our team has delivered more than 1.5 billion lateral flow tests to customers worldwide, and this new European certification only underscores our ongoing commitment to provide effective, high-quality diagnostic products at reasonable prices to more people around the world.”
Numerous scientific studies, along with ongoing public health screening of millions of people on a regular basis, have shown rapid antigen self-tests are an important tool for identifying infectious people quickly and equitably, even when they may not have symptoms of COVID-19 in ways that simply are not possible with slower, more expensive lab-based tests.
While the coronavirus continues to morph its genetic ribonucleic acid ("RNA") to generate new and potentially more contagious or more harmful variants, Innova's rapid antigen self-test - which detects multiple proteins in the virus - can provide an at-home way of helping to control the spread and reduce surges. When coupled with Innova's production capacity, the detection capabilities of its rapid antigen self-tests underline the company’s role as a critical partner to nations and businesses in containing more contagious strains.
Since its founding in 2020, Innova has put countless resources towards ensuring that its quality management system is compliant with ISO 13485:2016 Medical Devices – Quality Management Systems, Requirements for Regulatory, and US 21 CFR Part 820 Quality System Regulation, Requirements for Medical Devices.
The company has built a dedicated Quality Assurance and Regulatory Affairs team with expertise in quality and regulatory compliance matters.
