FDA Device Establishments · JSON-LD · Markdown

Specific Diagnostics

FEI 3023036790 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active

FEI Number3023036790
Owner / OperatorBIOMERIEUX SA (#8020790)
Address130 Baytech Dr, San Jose, CA, US
Registration expiry2026
Initial importer flagN
Registered products2
Product codes (top 20)LON, SAN
Regulation § (21 CFR)866.1645, 866.1650
Proprietary namesVITEK REVEAL Sealer; VITEK REVEAL Sensor Panel; VITEK REVEAL; VITEK REVEAL BC GN02-AST

External sources

Source: openFDA. Public-domain (CC0).