# Ortho Clinical Diagnostics, K.K.

FEI: 3012963943
Status: Active
Establishment types: Complaint File Establishment per 21 CFR 820.198
Owner/operator: QuidelOrtho Corporation (#2024674)

Address: East Tower 16F, GateCilty Osaki, Osaki 1-11-2,, Ortho Care Technical Support Center, Shinagawa-ku Tokyo, 141-0032, JP

Mandatory US Agent: Ortho-Clinical Diagnostics, Inc.

## Products

Total registered: 1
Top product codes: QKO
Regulation §: —

Proprietary names: VITROS Anti-SARS-CoV-2 IgG Quantitative Calibrator EUA210322, VITROS Anti-SARS-CoV-2 IgG Quantitative Controls EUA210322, VITROS Anti-SARS-CoV-2 Total N Controls EUA210355, VITROS Anti-SARS-CoV-2 Total N Antibody Calibrator EUA210355, VITROS Anti-SARS-CoV-2 Total N Antibody Reagent Pack EUA210355, VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack EUA210322

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223012963943%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3012963943