# Fujirebio Inc.

FEI: 3002895169
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: Fujirebio Diagnostics, Inc. (#10022860)

Address: 1-3-14 Tanashioda, Chuo-ku, Sagamihara-shi Kanagawa, 252-0245, JP

Mandatory US Agent: Fujirebio Diagnostics, Inc.

## Products

Total registered: 1
Top product codes: SET
Regulation §: 866.5840

Proprietary names: Lumipulse 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

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223002895169%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3002895169