PHASE SCIENTIFIC INTERNATIONAL LIMITED

Phase Scientific International Limited specializes in rapid in vitro diagnostic (IVD) tests designed to detect SARS-CoV-2 antigens. Their portfolio includes both clinical-use kits for healthcare professionals and self-testing devices for at-home use, such as the INDICAID COVID-19 Rapid Antigen Test and its at-home variant. These tests are specifically developed for point-of-care or individual testing to identify active COVID-19 infections.

Phase Scientific International Limited is headquartered in the United States. The company’s location in the US aligns with its focus on regulatory compliance and market distribution within the country, particularly for devices listed under the FDA’s systems.

Devices manufactured by Phase Scientific International Limited are listed in the FDA’s Unique Device Identifier (UDI) system. This registry is used for tracking and identifying medical devices in the United States, ensuring transparency and traceability for regulatory purposes.

The devices produced by Phase Scientific International Limited fall under Class N classification in the FDA’s system. This classification is typically assigned to diagnostic substrates, reagents, and kits that are not intended for use in supporting or maintaining life, nor are they used in preventing or correcting disease or injury. Instead, they are designed for detecting specific substances, such as SARS-CoV-2 antigens.