SUNNYVALE, Calif., Oct. 2, 2019 /PRNewswire/ -- Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration for Xpert BCR-ABL Ultra for monitoring disease burden ...
SUNNYVALE, Calif., May 29, 2019 /PRNewswire/ -- Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for testing throat and rectal specimens with its ...
SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This ...
SUNNYVALE, Calif., April 3, 2024 /PRNewswire/ -- Cepheid today announced that Xpert® HIV-1 Qual XC has been awarded World Health Organization (WHO) prequalification. Inclusion on the prequalification ...
The U.S. Food and Drug Administration issues the first emergency use authorization for a point-of-care Covid-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV 2 test. Cepheid is part of Danaher ...
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Health Canada grants licence to Cepheid’s HCV test
Health Canada has granted a medical device licence for Cepheid’s Xpert HCV VL Fingerstick, a test used to detect and quantify the hepatitis C virus (HCV) from a single blood drop. This advancement is ...
The U.S. FDA has granted an emergency use authorization (EUA) to Cepheid Inc., of Sunnyvale, Calif., for a rapid molecular diagnostic to detect SARS-CoV-2, the virus that causes COVID-19. The Xpert ...
Co announces it received clearance from the FDA to market its Xpert M.R.S.A test, which runs on the GeneXpert System, for the rapid detection of Methicillin-resistant Staphylococcus aureus. "Currently ...
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