FDA Device Establishments · JSON-LD · Markdown

Ortho Clinical Diagnostics, K.K.

FEI 3012963943 · Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number3012963943
Owner / OperatorQuidelOrtho Corporation (#2024674)
AddressEast Tower 16F, GateCilty Osaki, Osaki 1-11-2,, Ortho Care Technical Support Center, Shinagawa-ku Tokyo, 141-0032, JP
Mandatory US AgentOrtho-Clinical Diagnostics, Inc.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)QKO
Proprietary namesVITROS 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

External sources

Source: openFDA. Public-domain (CC0).