400 results · 51ms · Sources: EU EUDAMED, US FDA

Xpert® Xpress CoV-2 plus

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert® FII & FV

FDA 510(k)
FDA Class 2 ·Hematology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert MRSA/SA SSTI

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert vanA

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert® SA Nasal Complete

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert BCR-ABL 0%IS

FDA UDI
Mmqci·00852720008084·Reference material to monitor the performance o...

Xpert BCR-ABL IS p210 Linearity Panel C207

FDA UDI
Mmqci·00852720008183·Reference material to monitor the performance o...

Xpert BCR-ABL IS Panel C130

FDA UDI
Mmqci·00852720008060·Reference material to monitor the performance o...

QC Sets and Panels: Helix Elite™

FDA UDI
MICROBIOLOGICS INC.·70845357041240·Assayed Respiratory Control Panel

Xpert® GBS

Basic UDI-DI
EU IVDD · Eu Ivd General ·Cepheid·1 device

GeneXpert® Dx Systems

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Cepheid·3 devices

GeneXpert® Infinity Systems

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Cepheid·2 devices

Xpert® Check

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Cepheid·1 device

Xpert® FFPE Lysis Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Cepheid·1 device

Xpert® Urine Specimen Collection Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Cepheid·1 device

Xpert® Swab Specimen Collection Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Cepheid·1 device