400 results
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54ms
·
Sources: EU EUDAMED, US FDA
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
FDA 510(k)
FDA Class 2
·Microbiology
XPERT FLU/RSV XC ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System
FDA 510(k)
FDA Class 2
·Microbiology
XPERT MRSA/SA BLOOD CULTURE ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
XPERT CT/NG
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
FDA 510(k)
FDA Class 2
·Microbiology
XPERT C. DIFFICLE/EPI ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
XPERT MRSA/SA SSTI ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Carba-R
FDA 510(k)
FDA Class 2
·Microbiology
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
FDA 510(k)
FDA Class 2
·Hematology
XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065
FDA 510(k)
FDA Class 2
·Microbiology
Xpert® FII & FV
FDA 510(k)
FDA Class 2
·Hematology
XPERT, GENEXPERT DX SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Cepheid Xpert GBS LB Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
Cepheid Xpert CT/NG Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
Cepheid Xpert MRSA NxG Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
Cepheid Xpert SA Nasal Complete Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
Cepheid Xpert C. difficile/Epi Control Panel
FDA 510(k)
FDA Class 2
·Microbiology