# Ortho-Clinical Diagnostics

FEI: 3007111389
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: QuidelOrtho Corporation (#2024674)

Address: Felindre Meadows, Pencoed Bridgend, CF35 5PZ, GB

Mandatory US Agent: Ortho-Clinical Diagnostics, Inc.

## Products

Total registered: 2
Top product codes: LOM, SEI
Regulation §: 866.3172, 866.3173

Proprietary names: VITROS Anti-HBe Reagent Pack, VITROS Anti-HBe Calibrators

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223007111389%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3007111389