FDA Emergency Use Authorizations Approved for POC and OTC

PASADENA, CA, USA, April 4, 2024 /EINPresswire.com/ — OSANG Healthcare, a leading healthcare diagnostics company since 1996, has announced its Emergency Use Authorization (EUA) approval from the U.S. Food and Drug Administration (FDA) for COVID-19/Flu combo test. This is OSANG’s third approval of EUA, following GeneFinder COVID-19 Plus RealAmp Kit and OHC COVID-19 Antigen Self-Test.

This product offers a 3-in-1 testing capability, enabling it to identify not only the SARS-CoV-2 virus but also Influenza A and Influenza B with a single cassette, along with a dual-color line feature that significantly improves readability.

Two product lines were introduced to meet varied user requirements. The OHC COVID-19/Flu Antigen Test Pro, tailored for Point-of-Care (POC) settings such as labs and clinics, secured EUA on March 21st, 2024.

Following its approval, the QuickFinder TM COVID-19/Flu Antigen Self-Test obtained EUA on April 4th, 2024, for Over-the-Counter (OTC) use. Both lines will undergo the 510k process and shelf-life extension from 12 months to 24 months. This approval highlights the reliability and accuracy of the products, positioning them as invaluable tools for healthcare providers.

OSANG Healthcare will continue to be sincerely dedicated to public health and lead the way in healthcare diagnostics, encouraging individuals and communities worldwide to safeguard their health.

For more information about OSANG Healthcare and its products, visit www.osangllc.com.

About Osang Healthcare:

OHC is dedicated to addressing emerging diagnostic needs through innovative testing solutions across all settings, encompassing rapid at-home testing to point-of-care (POC) and lab-based molecular systems.

Established in 1996, OHC has maintained a leading position in the in vitro diagnostic (IVD) industry and is publicly listed. Our commitment extends to expanding our portfolio of POC medical devices, which includes glucose, ketone, cholesterol, and A1c analyzers for chronic illnesses, as well as COVID-19 & Flu Combo and Dengue rapid tests for infectious diseases.

Recognized for our global presence, OHC exports diagnostics to over 110 countries worldwide. For more information, please visit http://www.osanghc.com/en/home_en/ or contact Inhee Choi, PR for OHC at [email protected]

Sonia Awan
Outbloom Public Relations
[email protected]
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