FDA Device Establishments · JSON-LD · Markdown

ORASURE TECHNOLOGIES, INC.

FEI 3003297763 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active

FEI Number3003297763
Owner / OperatorORASURE TECHNOLOGIES, INC. (#9000083)
Address150 WEBSTER ST, Bethlehem, PA, US
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)MZO
Regulation § (21 CFR)866.3169
Proprietary namesOraQuick HCV Rapid Antibody Test

External sources

Source: openFDA. Public-domain (CC0).