GeneXpert Dx System

FDA UDI

CEPHEID·07332940006747·XPERT, GENEXPERT DX SYSTEM

GeneXpert Dx System

FDA UDI

CEPHEID·07332940004194·XPERT, GENEXPERT DX SYSTEM

Xpert Swab Specimen Collection Kit

FDA UDI

CEPHEID·07332940007003·Xpert Swab Specimen Collection Kit; 50 pack

Xpert MRSA/SA SSTI

FDA UDI

CEPHEID·07332940000189·Xpert MRSA/SA SSTI kit; 10 test kit

Xpert®

Device

EU IVDD · Eu Ivd General ·Cepheid AB·On the market·19 countries

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