56 results · 23ms · Sources: EU EUDAMED, US FDA

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