64 results
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48ms
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Sources: EU EUDAMED, US FDA
Filters
Fda510k
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Cepheid Xpert Respiratory Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
FDA 510(k)
FDA Class 1
·Microbiology
Xpert Xpress MVP; GeneXpert Xpress System
FDA 510(k)
FDA Class 2
·Microbiology
XPERT MTB/RIF ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
XPERT MRSA
FDA 510(k)
FDA Class 2
·Microbiology
XPERT MRSA/SA NASAL ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
FDA 510(k)
FDA Class 2
·Medical Genetics
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
FDA 510(k)
FDA Class 2
·Microbiology
XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Carba-R
FDA 510(k)
FDA Class 2
·Microbiology
Xpert VanA Assay
FDA 510(k)
FDA Class 2
·Microbiology
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Xpress Strep A
FDA 510(k)
FDA Class 2
·Microbiology
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems
FDA 510(k)
FDA Class 2
·Immunology
Xpert Xpress CoV-2/Flu/RSV plus
FDA 510(k)
FDA Class 2
·Microbiology
XPERT C. DIFFICILE
FDA 510(k)
FDA Class 1
·Microbiology
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Carba-R
FDA 510(k)
FDA Class 2
·Microbiology
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
FDA 510(k)
FDA Class 1
·Microbiology