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United PPE America CRISPR SARS-CoV-2 Test Kit for Covid-19 Received CE Certification for The European Market

United PPE America CRISPR SARS-CoV-2 Test Kit for Covid-19 Received CE Certification for The European Market


NEW JERSEY, USA, January 12, 2022 / -- United PPE America LLC ("UnitedPPE") is pleased to announce that its CRISPR SARS-CoV-2 Test Kit for the Novel Coronavirus ("COVID-19") has, on December 20, 2021, obtained the CE Certificate that conforms with the European Union (EU) directives and standards.

With this certification:
• UnitedPPE CRISPR SARS-CoV-2 Test Kit will affix the CE Mark for sale in EU countries
• Symbolize our product conforms with the stringent and essential requirements of the directives
• May issue EC declaration of conformity using CE mark as per EU IVD Medical Device Directive 98/79/EK

This announcement follows an agreement established between UnitedPPE and Sherlock Biosciences that granted UnitedPPE a license to develop and manufacture COVID-19 diagnostic tests using Sherlock Biosciences’ CRISPR-based technology. The agreement reflects Sherlock’s mission to expand testing access in response to the COVID-19 pandemic, while promoting global health equity.

The UnitedPPE CRISPR SARS-CoV-2 Test Kit utilizes Sherlock Biosciences’ CRISPR-based SHERLOCK technique to detect COVID-19, providing benefits including:

• Specificity and sensitivity on par with conventional PCR testing methods;
• Turnaround time from sample to read-out less than one hour;
• Deployable without expensive thermocycling machines; and,
• Low cost and easy implementation.

With the emergence of the new Omicron variant, many countries are continuing to ramp up their testing programs in an effort to curb the coronavirus pandemic. Given the increasing concerns over COVID-19 variants, there is a continued and growing demand for simple, fast and accurate solutions to control and reduce the spread of COVID-19.

“Sherlock Biosciences has long recognized that implementing a multi-faceted testing strategy is critical to combating the spread of COVID-19. Our proprietary CRISPR diagnostic technology has enabled increased access to diagnostics globally,” said Bryan Dechairo, President and CEO of Sherlock Biosciences. “We congratulate our partner, UnitedPPE, on this milestone and are gratified to see the reliability of CRISPR-based diagnostics validated with the European CE Certificate.”

About United PPE America
United PPE America aims at delivering premium products and providing solutions to our clients. We are conscious that our products improve patients' lives, and we channel this pride and responsibility in everything we do.

"We are excited to expand access to COVID-19 diagnostics by bringing Sherlock’s CRISPR platform to the European market," said Peter Hon Chong, CEO of United PPE America. "Our vast production and distribution abilities throughout Asia and European will ensure that these critical diagnostics can be rapidly deployed to aid in the fight against this global pandemic."

United PPE America is spearheading the path to healthcare advancement, delivering problem-solving and cutting-edge technologies. Our scientists work every day to improve Human health, thanks to our production capabilities, and our expertise, we aim for United PPE America to become a leading manufacturer of CRISPR-based COVID diagnostics.

For additional information, please visit

Peter Hon Chong
United PPE America
+1 917-459-3628
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