11 results
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72ms
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Sources: EU EUDAMED, US FDA
MOCK PIE
FDA UDI
GenePoc Inc·00628055344032·The MOCK PIE is a re-usable PIE intended for us...
GenePOC™ Strep A
FDA UDI
GenePoc Inc·00628055344087·The GenePOC Strep A assay, performed on the rev...
GenePOC™ GBS LB
FDA UDI
GenePoc Inc·00628055344018·The GenePOC™ GBS LB assay performed on the revo...
GenePOC™ Carba
FDA UDI
GenePoc Inc·00628055344070·The GenePOC™ Carba assay, performed on the revo...
GenePOC™ CDiff
FDA UDI
GenePoc Inc·00628055344025·The GenePOC™ CDiff assay performed on the revog...
revogene™
FDA UDI
GenePoc Inc·00628055344001·The revogene™ instrument is intended for in vit...
GenePOC CDiff
FDA 510(k)
FDA Class 2
·Microbiology
GenePOC Carba
FDA 510(k)
FDA Class 2
·Microbiology
GenePOC GBS LB
FDA 510(k)
FDA Class 1
·Microbiology
revogene
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GenePOC Strep A
FDA 510(k)
FDA Class 2
·Microbiology