400 results
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51ms
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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