BEUDAMED
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    Filters FDA Enforcement × Classification: Class Iii × Clear all

    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

    FDA Enforcement
    Class III ·Terminated·Cepheid·August 26, 2015

    Cepheid Xpert C. difficile/Epi Control Panel

    FDA Enforcement
    Class III ·Ongoing·Microbiologics Inc·June 26, 2019

    Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

    FDA Enforcement
    Class III ·Terminated·Cepheid·August 26, 2015