56 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Xpert HCV; GeneXpert Xpress System
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Xpress Strep A
FDA 510(k)
FDA Class 2
·Microbiology
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
FDA 510(k)
FDA Class 2
·Microbiology
Xpert MRSA NxG
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
FDA 510(k)
FDA Class 2
·Microbiology
Xpert CT/NG
FDA 510(k)
FDA Class 2
·Microbiology
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
FDA 510(k)
FDA Class 2
·Microbiology
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Xpress Flu, 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 FLU
FDA 510(k)
FDA Class 2
·Microbiology
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 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