Recently, three products of Orient Gene and its wholly-owned subsidiary, Healgen, have obtained overseas certification. Among which, the Healgen URS Test Strip has obtained FDA certification, the COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) and the COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) have obtained UK CTDA certification.
The Healgen URS Test Strip has obtained FDA certification, which can meet the self-health management needs of users’ home self-testing, and enrich the company’s self-testing product line in the US market.
US FDA | Certificate Holder: Healgen
Healgen URS Test Strip
Intended use: This product is an over-the-counter urine test strip for qualitative detection of white blood cells and nitrite indicators in urine to help screen for urinary tract infection (UTI).
Certificate No.: K231045
The COVID-19 Combo Rapid Test Cassette, a detection product for COVID-19 and other respiratory viruses, can detect a variety of pathogens at the same time with only one sampling, which has the advantages of rapid, simple and economical. The product has been developed and certified in the EU in 2021, and this new addition has been approved by the UK CTDA.
UK CTDA | Certificate Holder: Orient Gene
COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
Intended use: This product is used for qualitative detection of COVID-19 and Flu A&B specimens in nasal swabs to help in the rapid differential diagnosis of respiratory COVID-19 or Flu A&B infections.
COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)
Intended use
This product is used for qualitative detection of COVID-19, Flu A&B, RSV and Adeno specimens in nasal swabs to help in the rapid differential diagnosis of respiratory COVID-19, Flu A&B, RSV or Adeno infections.
Orient Gene will adhere to the strategic objective of “focusing on IVD and improving the industrial chain layout”, continue multi-direction research, launch more products and services, develop related test cassettes and instruments, and make full contributions to the development of global medical and health services.
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