64 results · 48ms · Sources: EU EUDAMED, US FDA
Filters Fda510k ×

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