FDA Device Establishments · JSON-LD · Markdown

Fujirebio Inc.

FEI 3002895169 · Manufacture Medical Device · Status: Active

FEI Number3002895169
Owner / OperatorFujirebio Diagnostics, Inc. (#10022860)
Address1-3-14 Tanashioda, Chuo-ku, Sagamihara-shi Kanagawa, 252-0245, JP
Mandatory US AgentFujirebio Diagnostics, Inc.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)SET
Regulation § (21 CFR)866.5840
Proprietary namesLumipulse G pTau 217 Plasma IC; Lumipulse G pTau 217 Plasma Calibrators; Lumipulse G B-Amyloid 1-42-N Plasma Calibrators; Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio; Lumipulse G B-Amyloid 1-42-N Plasma IC

External sources

Source: openFDA. Public-domain (CC0).