FDA Device Establishments · JSON-LD · Markdown

Ortho-Clinical Diagnostics

FEI 3007111389 · Manufacture Medical Device · Status: Active

FEI Number3007111389
Owner / OperatorQuidelOrtho Corporation (#2024674)
AddressFelindre Meadows, Pencoed Bridgend, CF35 5PZ, GB
Mandatory US AgentOrtho-Clinical Diagnostics, Inc.
Registration expiry2026
Initial importer flagN
Registered products2
Product codes (top 20)LOM, SEI
Regulation § (21 CFR)866.3172, 866.3173
Proprietary namesVITROS Anti-HBe Reagent Pack; VITROS Anti-HBe Calibrators

External sources

Source: openFDA. Public-domain (CC0).