# Ortho Clinical Diagnostics

FEI: 3002642396
Status: Active
Establishment types: Complaint File Establishment per 21 CFR 820.198
Owner/operator: QuidelOrtho Corporation (#2024674)

Address: 1 International Business Park, The Synergy, #01-11/12, Singapore South West, 609917, SG

Mandatory US Agent: Ortho-Clinical Diagnostics, Inc.

## Products

Total registered: 3
Top product codes: JJX, DDG, JIT
Regulation §: 862.1660, 866.5880, 862.1150

Proprietary names: VITROS TRFRN Reagent, VITROS Protein Performance Verifiers, VITROS Calibrator Kit 20

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223002642396%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3002642396