SUNNYVALE, Calif., May 2, 2018 /PRNewswire/ -- Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and waiver under the Clinical Laboratory ...
In an attempt to strengthen its foothold in the virology market, molecular diagnostics corporation Cepheid ( CPHD), together with the not-for-profit organization - Foundation for Innovative New ...
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 ...
Detection of hepatitis C virus (HCV) in about an hour SUNNYVALE, Calif., June 27, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical ...
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., June 4, 2025 /CNW/ -- Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert ® HIV-1 Viral Load XC, a next-generation extended-coverage (XC ...
SUNNYVALE, Calif., Nov. 16, 2022 /PRNewswire/ -- Cepheid today announced the availability of Xpert ® GBS LB XC (extended coverage), a molecular diagnostic test for qualitative detection of Group B ...
SUNNYVALE, Calif., Feb. 14, 2023 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration for Xpert Mpox, which runs on ...
Cepheid has announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert™ MRSA test, which runs on the GeneXpert® System, for the detection of ...